Methods and systems for data analysis

ABSTRACT

Provided herein are systems, methods, and computer readable medium for entering, identifying, and aggregating data for analysis data in an electronic device, wherein the data are from a plurality of multi-participant surveys.

CROSS REFERENCE

This application claims the benefit of U.S. Provisional PatentApplication No. 61/564,654, filed Nov. 29, 2011, which is hereinincorporated by reference in its entirety.

BACKGROUND

There is a need for devices, apparatus, systems, and methods forcollecting and recording information from a plurality ofmulti-participant surveys, e.g., clinical trials, on a single electronicdevice. Furthermore, there is a need for systems and methods fortransmitting data from a plurality of multi-participant surveys storedon a single electronic device to a staging data repository, and thentransmitting data from the staging data repository to selected studydata repositories.

SUMMARY OF THE INVENTION

In one aspect, a method for managing data on an electronic device isprovided, wherein the data are from a plurality of multi-participantsurveys, wherein the data are managed for analysis, the methodcomprising: a) entering data from a first participant in a firstmulti-participant survey into the electronic device, wherein the datafrom the first participant are identified for analysis as being from thefirst participant or as being from the first multi-participant survey;b) entering data from a second participant in a second multi-participantsurvey into the electronic device, wherein the first multi-participantsurvey is different from the second multi-participant survey, andwherein the data from the second participant are identified for analysisas being from the second participant or as being from the secondmulti-participant survey; and c) aggregating the data from the firstparticipant or the data from the first multi-participant survey foranalysis, and aggregating the data from the second participant or thedata from the second multi-participant survey for analysis.

In some embodiments, the data from the first participant comprise datafrom the first multi-participant survey, and the data from the secondparticipant comprise data from the second multi-participant survey. Insome embodiments, the method further comprises recording the data fromthe first participant in the first multi-participant survey and the datafrom the second participant in the second multi-participant survey onthe electronic device. In some embodiments, the device is not a handheldelectronic device. In some embodiments, the device is a workstation. Insome embodiments, the electronic device is a handheld electronic device.In some embodiments, the handheld electronic device is a personaldigital assistant, tablet computer, or a telephone. In some embodiments,the electronic device is connected to the Internet.

In some embodiments, the first multi-participant survey and the secondmulti-participant survey are concurrent. In some embodiments, the firstmulti-participant survey ends before the second multi-participant surveybegins. In some embodiments, the first participant and the secondparticipant are the same person. In some embodiments, the firstparticipant and the second participant are different people. In someembodiments, the first participant enters the data from the firstmulti-participant survey into the electronic device, and the secondparticipant enters the data from the second multi-participant surveyinto the electronic device. In some embodiments, a first individualenters the data from the first participant in the firstmulti-participant survey into the device, and a second individual entersthe data from second participant in the second multi-participant surveyinto the device. In some embodiments, the first individual is ahealthcare provider and the second individual is a healthcare provider.In some embodiments, the first individual and the second individual arethe same healthcare provider. In some embodiments, the method furthercomprises entering data from at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 50,100, 1000, 10,000, 100,000, or 1,000,000 multi-participant surveys intothe device.

In some embodiments, a plurality of participants participates in thefirst multi-participant survey and a plurality of participantsparticipates in the second multi-participant survey. In someembodiments, the electronic device is in electronic communication with astaging data repository. In some embodiments, the staging datarepository is a server. In some embodiments, the method furthercomprises transmitting the data identified as being from the firstparticipant in the first multi-participant survey to the staging datarepository and transmitting the data identified as being from the secondparticipant in the second multi-participant survey to the staging datarepository. In some embodiments, the method further comprisestransmitting the data identified as being from the firstmulti-participant survey to the staging data repository and transmittingthe data identified as being from the second multi-participant survey tothe staging data repository.

In some embodiments, the staging data repository is in electroniccommunication with a plurality of study data repositories, wherein theplurality of study data repositories comprises a first study datarepository and a second study data repository. In some embodiments, themethod further comprises transferring, from the staging data repository,the data identified as being from the first participant in the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second participant in the secondmulti-participant survey to the second study data repository. In someembodiments, the method further comprises transferring, from the stagingdata repository, the data identified as being from the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second multi-participant survey to thesecond study data repository.

In some embodiments, the method further comprises locking at least oneof the plurality of study data repositories. In another embodiment, themethod further comprises adding a new study data repository to theplurality of study data repositories, wherein the new study datarepository is in electronic communication with the staging datarepository. In another embodiment, the plurality of study datarepositories comprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100,1000, 10,000, 100,000, or 1,000,000 study data repositories.

In some embodiments, the plurality of multi-participant surveys is aplurality of clinical trials. In some embodiments, the plurality ofmulti-participant surveys is a plurality of market research surveys. Insome embodiments, the plurality of multi-participant surveys is aplurality of political research surveys. In some embodiments, the methodfurther comprises providing the electronic device to a site, wherein aplurality of participants communicates with the site. In someembodiments, the site is a hospital, medical clinic, or laboratory. Insome embodiments, the plurality of participants communicates with thesite through in-person visits. In some embodiments, the plurality ofparticipants communicates with the site electronically. In someembodiments, the electronic communication comprises an e-mail, text,telephone call, or voice message.

In some embodiments, the method further comprises providing theelectronic device to the first participant. In some embodiments, dataidentified as being from the first participant in the firstmulti-participant study are transferred from the staging data repositoryto the second study data repository, further comprising transferring,from the second study data repository to the first study datarepository, the data identified as being from the first participant inthe first multi-participant study that were transferred from the stagingdata repository to the second study data repository.

In another aspect, a computer readable medium having stored thereonsequences of instructions is provided which, when executed by a computersystem, cause the computer system to perform: a) accepting data from afirst participant in a first multi-participant survey in an electronicdevice, wherein the data from the first participant are identified foranalysis as being from the first participant or as being from the firstmulti-participant survey; b) accepting data from a second participant ina second multi-participant survey in the electronic device, wherein thefirst multi-participant survey is different from the secondmulti-participant survey, and wherein the data from the secondparticipant are identified for analysis as being from the secondparticipant or as being from the second multi-participant survey; and c)aggregating the data from the first participant or the data from thefirst multi-participant survey for analysis, and aggregating the datafrom the second participant or the data from the secondmulti-participant survey for analysis.

In some embodiments, the data from the first participant comprise datafrom the first multi-participant survey, and the data from the secondparticipant comprise data from the second multi-participant survey. Insome embodiments, the computer system further performs recording thedata from the first participant in the first multi-participant surveyand the data from the second participant in the second multi-participantsurvey on the electronic device. In some embodiments, the device is nota handheld electronic device. In some embodiments, the device is aworkstation. In some embodiments, the electronic device is a handheldelectronic device. In some embodiments, the handheld electronic deviceis a personal digital assistant, tablet computer, or a telephone. Insome embodiments, the electronic device is connected to the Internet.

In some embodiments, the first multi-participant survey and the secondmulti-participant survey are concurrent. In some embodiments, the firstmulti-participant survey ends before the second multi-participant surveybegins. In some embodiments, the first participant and the secondparticipant are the same person. In some embodiments, the firstparticipant and the second participant are different people.

In some embodiments, the accepting the data from the first participantcomprises accepting data input by the first participant, and theaccepting the data from the second participant comprises accepting datainput by the second participant. In some embodiments, the accepting thedata from the first participant comprises accepting data input by afirst individual, and accepting the data from the second participantcomprises accepting data input by a second individual. In someembodiments, the first individual is a healthcare provider and thesecond individual is a healthcare provider. In some embodiments, thefirst individual and the second individual are the same healthcareprovider.

In some embodiments, the computer readable medium has stored thereonsequences of instructions which, when executed by a computer system,cause the computer system to perform accepting data from at least 2, 3,4, 5, 6, 7, 8, 9, 10, 50, 100, 1000, 10,000, 100,000, or 1,000,000multi-participant surveys into the device. In some embodiments, aplurality of participants participates in the first multi-participantsurvey and a plurality of participants participates in the secondmulti-participant survey. In some embodiments, the electronic device isin electronic communication with a staging data repository. In someembodiments, the staging data repository is a server. In someembodiments, the computer readable medium has stored thereon sequencesof instructions which, when executed by a computer system, cause thecomputer system to perform transmitting the data identified as beingfrom the first participant in the first multi-participant survey to thestaging data repository and transmitting the data identified as beingfrom the second participant in the second multi-participant survey tothe staging data repository. In some embodiments, the computer readablemedium has stored thereon sequences of instructions which, when executedby a computer system, cause the computer system to perform transmittingthe data identified as being from the first multi-participant survey tothe staging data repository and transmitting the data identified asbeing from the second multi-participant survey to the staging datarepository.

In some embodiments, the staging data repository is in electroniccommunication with a plurality of study data repositories, wherein theplurality of study data repositories comprises a first study datarepository and a second study data repository. In some embodiments, thecomputer readable medium has stored thereon sequences of instructionswhich, when executed by a computer system, cause the computer system toperform transferring, from the staging data repository, the dataidentified as being from the first participant in the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second participant in the secondmulti-participant survey to the second study data repository. In someembodiments, the computer readable medium has stored thereon sequencesof instructions which, when executed by a computer system, cause thecomputer system to perform transferring, from the staging datarepository, the data identified as being from the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second multi-participant survey to thesecond study data repository.

In some embodiments, the computer readable medium has stored thereonsequences of instructions which, when executed by a computer system,cause the computer system to perform locking at least one of theplurality of study data repositories. In some embodiments, the pluralityof study data repositories comprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10,50, 100, 1000, 10,000, 100,000, or 1,000,000 study data repositories.

In some embodiments, the plurality of multi-participant surveys is aplurality of clinical trials. In some embodiments, the plurality ofmulti-participant surveys is a plurality of market research surveys. Insome embodiments, the plurality of multi-participant surveys is aplurality of political research surveys.

In some embodiments, the electronic device is located at a site. In someembodiments, the site is a hospital, medical clinic, or laboratory. Insome embodiments, the electronic device accepts data from a plurality ofparticipants that communicates with the site through in-person visits.In some embodiments, the electronic device accepts data from a pluralityof participants that communicates with the site electronically. In someembodiments, the electronic communication comprises an e-mail, text,telephone call, or voice message.

In some embodiments, data identified as being from the first participantin the first multi-participant study is transferred from the stagingdata repository to the second study data repository, and the computersystem further performs transferring, from the second study datarepository to the first study data repository, the data identified asbeing from the first participant in the first multi-participant studythat was transferred from the staging data repository to the secondstudy data repository.

In another aspect, a system for managing data from a plurality ofmulti-participant surveys is provided, the system comprising computerreadable instructions for: a) accepting data from a first participant ina first multi-participant survey in an electronic device, wherein thedata from the first participant are identified for analysis as beingfrom the first participant or as being from the first multi-participantsurvey; b) accepting data from a second participant in a secondmulti-participant survey in the electronic device, wherein the firstmulti-participant survey is different from the second multi-participantsurvey, and wherein the data from the second participant are identifiedfor analysis as being from the second participant or as being from thesecond multi-participant survey; and c) aggregating the data from thefirst participant or the data from the first multi-participant surveyfor analysis, and aggregating the data from the second participant orthe data from the second multi-participant survey for analysis.

In some embodiments, the data from the first participant comprise datafrom the first multi-participant survey, and the data from the secondparticipant comprise data from the second multi-participant survey. Insome embodiments, the system further comprises computer readableinstructions for recording the data from the first participant in thefirst multi-participant survey and the data from the second participantin the second multi-participant survey on the electronic device.

In some embodiments, the device is not a handheld electronic device. Insome embodiments, the device is a workstation. In some embodiments, theelectronic device is a handheld electronic device. In some embodiments,the handheld electronic device is a personal digital assistant, tabletcomputer, or a telephone. In some embodiments, the electronic device isconnected to the Internet.

In some embodiments, the first multi-participant survey and the secondmulti-participant survey are concurrent. In some embodiments, the firstmulti-participant survey ends before the second multi-participant surveybegins. In some embodiments, the first participant and the secondparticipant are the same person. In some embodiments, the firstparticipant and the second participant are different people. In someembodiments, the accepting the data from the first participant comprisesaccepting data input by the first participant, and the accepting thedata from the second participant comprises accepting data input by thesecond participant. In some embodiments, the accepting the data from thefirst participant comprises accepting data input by a first individual,and accepting the data from the second participant comprises acceptingdata input by a second individual. In some embodiments, the firstindividual is a healthcare provider and the second individual is ahealthcare provider.

In some embodiments, the first individual and the second individual arethe same healthcare provider. In some embodiments, the system furthercomprises computer readable instructions for accepting data from atleast 2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100, 1000, 10,000, 100,000, or1,000,000 multi-participant surveys into the device. In someembodiments, a plurality of participants participates in the firstmulti-participant survey and a plurality of participants participates inthe second multi-participant survey. In some embodiments, the electronicdevice is in electronic communication with a staging data repository. Insome embodiments, the staging data repository is a server. In someembodiments, the system further comprises computer readable instructionsfor transmitting the data identified as being from the first participantin the first multi-participant survey to the staging data repository andtransmitting the data identified as being from the second participant inthe second multi-participant survey to the staging data repository.

In some embodiments, the system further comprises computer readableinstructions for transmitting the data identified as being from thefirst multi-participant survey to the staging data repository andtransmitting the data identified as being from the secondmulti-participant survey to the staging data repository. In someembodiments, the staging data repository is in electronic communicationwith a plurality of study data repositories, wherein the plurality ofstudy data repositories comprises a first study data repository and asecond study data repository.

In some embodiments, the system further comprises computer readableinstructions for transferring, from the staging data repository, thedata identified as being from the first participant in the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second participant in the secondmulti-participant survey to the second study data repository. In someembodiments, the system further comprises computer readable instructionsfor transferring, from the staging data repository, the data identifiedas being from the first multi-participant survey to the first study datarepository and the data identified as being from the secondmulti-participant survey to the second study data repository.

In some embodiments, the system further comprises computer readableinstructions for locking at least one of the plurality of study datarepositories. In some embodiments, the plurality of study datarepositories comprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100,1000, 10,000, 100,000, or 1,000,000 study data repositories. In someembodiments, the plurality of multi-participant surveys is a pluralityof clinical trials. In some embodiments, the plurality ofmulti-participant surveys is a plurality of market research surveys. Insome embodiments, the plurality of multi-participant surveys is aplurality of political research surveys.

In some embodiments, the electronic device is located at a site. In someembodiments, the site is a hospital, medical clinic, or laboratory. Insome embodiments, the electronic device accepts data from a plurality ofparticipants that communicates with the site through in-person visits.In some embodiments, the electronic device accepts data from a pluralityof participants that communicates with the site electronically. In someembodiments, the electronic communication comprises an e-mail, text,telephone call, or voice message.

In some embodiments, data identified as being from the first participantin the first multi-participant study is transferred from the stagingdata repository to the second study data repository, and the systemcomprises computer readable instructions for transferring, from thesecond study data repository to the first study data repository, thedata identified as being from the first participant in the firstmulti-participant study that was transferred from the staging datarepository to the second study data repository.

In another aspect, a system for managing data from a plurality ofmulti-participant surveys is provided, said system comprising: a) anelectronic device, wherein said electronic device comprises: i.) logicfor receiving data from a first participant in a first multi-participantsurvey, wherein the data from the first participant are identified foranalysis as being from the first participant or as being from the firstmulti-participant survey; ii.) logic for receiving data from a secondparticipant in a second multi-participant survey into the electronicdevice, wherein the first multi-participant survey is different from thesecond multi-participant survey, and wherein the data from the secondparticipant are identified for analysis as being from the secondparticipant or as being from the second multi-participant survey; iii.)logic for aggregating the data from the first participant or the datafrom the first multi-participant survey for analysis; iv.) logic foraggregating the data from the second participant or the data from thesecond multi-participant survey for analysis; and v.) storage adapted tostore the aggregated data from the first participant or the data fromthe first multi-participant survey and the aggregated data from thesecond participant or the data from the second multi-participant survey;b) a staging data repository comprising: i.) an interface forcommunication with said electronic device; ii.) logic for receiving datafrom said electronic device through said communication interface; iii.)storage adapted to receive the aggregated data from the firstparticipant or the data from the first multi-participant survey and theaggregated data from the second participant or the data from the secondmulti-participant survey; and c) a plurality of study data repositories,where the plurality of study data repositories comprise i.) an interfacefor communication with said staging data repository; ii.) logic forreceiving data from said staging data repository; and iii.) logic forprocessing data from said staging data repository.

In some embodiments, the data from the first participant comprise datafrom the first multi-participant survey, and the data from the secondparticipant comprise data from the second multi-participant survey. Insome embodiments, the electronic device comprises logic for recordingthe data from the first participant in the first multi-participantsurvey and the data from the second participant in the secondmulti-participant survey on the electronic device.

In some embodiments, the electronic device is not a handheld electronicdevice. In some embodiments, the device is a workstation. In someembodiments, the electronic device is a handheld electronic device. Insome embodiments, the handheld electronic device is a personal digitalassistant, tablet computer, or a telephone. In some embodiments, theelectronic device is connected to the Internet.

In some embodiments, the logic comprises electronic circuitry. In someembodiments, the logic comprises computer program code. In someembodiments, the logic comprises electronic circuitry and computerprogram code.

In some embodiments, the first multi-participant survey and the secondmulti-participant survey are concurrent. In some embodiments, the firstmulti-participant survey ends before the second multi-participant surveybegins. In some embodiments, the first participant and the secondparticipant are the same person. In some embodiments, the firstparticipant and the second participant are different people. In someembodiments, the first participant enters the data from the firstmulti-participant survey into the electronic device, and the secondparticipant enters the data from the second multi-participant surveyinto the electronic device.

In some embodiments, a first individual enters the data from the firstparticipant in the first multi-participant survey into the device, and asecond individual enters the data from second participant in the secondmulti-participant survey into the device. In some embodiments, the firstindividual is a healthcare provider and the second individual is ahealthcare provider. In some embodiments, the first individual and thesecond individual are the same healthcare provider. In some embodiments,the electronic device further comprises logic for receiving data from atleast 2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100, 1000, 10,000, 100,000, or1,000,000 or more multi-participant surveys into the electronic device.

In some embodiments, the data identified as being from the firstparticipant in the first multi-participant survey is transmitted to thestaging data repository and the data identified as being from the secondparticipant in the second multi-participant survey is transmitted to thestaging data repository. In some embodiments, the data identified asbeing from the first multi-participant survey is transmitted to thestaging data repository and the data identified as being from the secondmulti-participant survey is transmitted to the staging data repository.In some embodiments, the data identified as being from the firstparticipant in the first multi-participant survey is transferred fromthe staging data repository to the first study data repository and thedata identified as being from the second participant in the secondmulti-participant survey is transferred from the staging data repositoryto the second study data repository.

In some embodiments, the data identified as being from the firstmulti-participant survey is transferred from the staging data repositoryto the first study data repository and the data identified as being fromthe second multi-participant survey is transferred from the staging datarepository to the second study data repository. In some embodiments, atleast one of the plurality of study data repositories is locked. In someembodiments, a new study data repository is added to the plurality ofstudy data repositories, wherein the new study data repository is inelectronic communication with the staging data repository. In someembodiments, the plurality of study data repositories comprise at least2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100, 1000, 10,000, 100,000, or 1,000,000study data repositories.

In some embodiments, the plurality of multi-participant surveys is aplurality of clinical trials. In some embodiments, the plurality ofmulti-participant surveys is a plurality of market research surveys. Insome embodiments, the plurality of multi-participant surveys is aplurality of political research surveys.

In some embodiments, the electronic device is provided to a site,wherein a plurality of participants communicates with the site. In someembodiments, the site is a hospital, medical clinic, or laboratory. Insome embodiments, the plurality of participants communicates with thesite through in-person visits. In some embodiments, the plurality ofparticipants communicates with the site electronically. In someembodiments, the electronic communication comprises an e-mail, text,telephone call, or voice message. In some embodiments, the electronicdevice is provided to the first participant. In some embodiments, aplurality of participants participates in the first multi-participantsurvey and a plurality of participants participates in the secondmulti-participant survey.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

Novel features are set forth with particularity in the appended claims.A better understanding of the features and advantages will be obtainedby reference to the following detailed description that sets forthillustrative embodiments and the accompanying drawings of which:

FIG. 1A and FIG. 1B illustrate entry of data from a plurality ofmulti-participant surveys into an electronic device.

FIG. 2 illustrates transfer of data from a plurality ofmulti-participant surveys from an electronic device to a staging datarepository and transfer of data from a first multi-participant survey toa first study data repository and transfer of data from a secondmulti-participant survey to a second study data repository.

FIG. 3 illustrates locking of study data repository 2 to prevent datafrom entering study data repository 2.

FIG. 4 illustrates transfer of data erroneously transferred to studydata repository 2 to the correct study data repository 1.

FIG. 5 illustrates an example of a network or host computer platform ascan be used to implement a server or electronic devices, according to anembodiment.

FIG. 6 depicts a computer or electronic device with user interfaceelements, as can be used to implement a personal computer, electronicdevice, or other type of work station or terminal device according to anembodiment, although the computer or electronic device of FIG. 6 canalso act as a server if appropriately programmed

DETAILED DESCRIPTION OF THE INVENTION Overview

In general, devices, methods, computer readable medium, and systems areprovided herein for managing data on an electronic device, wherein thedata can be from a plurality of multi-participant surveys (e.g.,clinical trials). Data from a plurality of multi-participant surveys canbe entered, identified for further analysis, and/or aggregated on one ormore electronic devices. In some cases, unique protocol or studyidentification is applied to data (e.g., subject data) each time data isentered into a device. In some cases, the subject is a patient in astudy, e.g., a clinical trial. One or more devices can be used tocollect data for one or more multi-participant studies and/or protocolswithin a study. The devices, methods, computer readable medium, andsystems provided herein can transfer data from a plurality ofmulti-participant surveys on one or more electronic devices to a stagingdata repository. Data in a staging data repository can be transferred(sifted) from the staging data repository to one or more study datarepositories. The transfer of data from a staging data repository to astudy data repository can be based on identifying information of aparticipant in a multi-participant survey and/or information identifyingthe multi-participant survey. The identifying information can becaptured when datum or data are entered into a device.

The computer-readable medium described herein can be non-transitory.Non-transitory computer-readable media can comprise allcomputer-readable media, with the sole exception being a transitory,propagating signal.

In one embodiment, multiple subjects can enter data from differentmulti-participant surveys into an electronic device. For example, FIG.1A illustrates a first subject in a first multi-participant surveyentering data into an electronic device, and a second subject in asecond multi-participant survey entering data into the electronicdevice. In some cases, a plurality of subjects (e.g., greater than 10,greater than 100, greater than 1000, greater than 10,000, greater than100,000, or greater than 1,000,000) enters data into the electronicdevice. In some cases, about 100 to about 1000, about 1000 to about10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 subjects enter data into an electronic device. In anotherembodiment, a single subject in a plurality of multi-participant surveyscan enter data from the plurality of multi-participant surveys into anelectronic device. For example, FIG. 1B illustrates a first subject in afirst multi-participant survey and a second multi-participant surveyentering data from the first multi-participant survey and the secondmulti-participant survey into an electronic device. In some cases, asubject enters data from a plurality of multi-participant surveys (e.g.,greater than 10, greater than 100, greater than 1000, greater than10,000, greater than 100,000, or greater than 1,000,000) into anelectronic device. In some cases, a subject enters data from about 10 toabout 100, about 100 to about 1000, about 1000 to about 10,000, about10,000 to about 100,000, or about 100,000 to about 1,000,000multi-participant surveys into an electronic device.

In some cases, each subject in a multi-participant survey enters datainto a separate electronic device. In some cases, each subject in amulti-participant survey has, or is provided, an electronic device,e.g., a portable electronic device, e.g., a handheld electronic device.In some cases, about, more than, less than, or at least 2, 3, 4, 5, 6,7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500,600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000,9000, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000,90,000, 100,000, 200,000, 300,000, 400,000, 500,000, 600,000, 700,000,800,000, 900,000, 1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000,6,000,000, 7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000,30,000,000, 40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000,90,000,000, or 100,000,000 electronic devices are used, or provided tosubjects in one or more multi-participant surveys. In some cases, about2 to about 10, about 10 to about 100, about 100 to about 1000, about1000 to about 10,000, about 10,000 to about 100,000, about 100,000 toabout 1,000,000, about 1,000,000 to about 10,000,000, about 10,000,000to about 100,000,000 electronic devices are used, or provided tosubjects in one or more multi-participant studies.

In one aspect, a method for managing data on an electronic device isprovided herein, wherein the data are from a plurality ofmulti-participant surveys, and wherein the data are managed foranalysis. The method can comprise entering data from a first participantin a first multi-participant survey into the electronic device, whereinthe data from the first participant is identified for analysis as beingfrom the first participant and/or as being from the firstmulti-participant survey. The method can comprise entering data from asecond participant in a second multi-participant survey into theelectronic device, wherein the first multi-participant survey isdifferent from the second multi-participant survey, and wherein the datafrom the second participant is identified for analysis as being from thesecond participant and/or as being from the second multi-participantsurvey. The method can comprise aggregating the data from the firstparticipant or the data from the first multi-participant survey foranalysis, and aggregating the data from the second participant or thedata from the second multi-participant survey for analysis. In somecases, data from a plurality of multi-participant surveys (e.g., greaterthan 10, greater than 100, greater than 1000, greater than 10,000,greater than 100,000, or greater than 1,000,000) are aggregated; in somecases, data from a plurality of subjects (e.g., greater than 10, greaterthan 100, greater than 1000, greater than 10,000, greater than 100,000,or greater than 1,000,000) are aggregated. In some cases, data fromabout 10 to about 100, about 100 to about 1000, about 1000 to about10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 multi-participant surveys are aggregated. In some cases, datafrom about 10 to about 100, about 100 to about 1000, about 1000 to about10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 subjects are aggregated.

In another aspect, a computer readable medium is provided herein havingstored thereon sequences of instructions. The instructions, whenexecuted by a computer system, can cause the computer system to acceptdata from a first participant in a first multi-participant survey in anelectronic device, wherein the data from the first participant isidentified for analysis as being from the first participant and/or asbeing from the first multi-participant survey. The instructions cancause the computer system to accept data from a second participant in asecond multi-participant survey in the electronic device, wherein thefirst multi-participant survey is different from the secondmulti-participant survey, and wherein the data from the secondparticipant is identified for analysis as being from the secondparticipant or as being from the second multi-participant survey. Theinstructions can cause the computer system to aggregate the data fromthe first participant and/or the data from the first multi-participantsurvey for analysis, and aggregate the data from the second participantand/or the data from the second multi-participant survey for analysis.In some cases, data from a plurality of multi-participant surveys (e.g.,greater than 10, greater than 100, greater than 1000, greater than10,000, greater than 100,000, or greater than 1,000,000) are aggregated;in some cases, data from a plurality of subjects (e.g., greater than 10,greater than 100, greater than 1000, greater than 10,000, greater than100,000, or greater than 1,000,000) are aggregated. In some cases, datafrom about 10 to about 100, about 100 to about 1000, about 1000 to about10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 multi-participant surveys are aggregated. In some cases, datafrom about 10 to about 100, about 100 to about 1000, about 1000 to about10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 subjects are aggregated.

In another aspect, a system for managing data from a plurality ofmulti-participant surveys is provided herein. The system can comprisecomputer readable instructions for accepting data from a firstparticipant in a first multi-participant survey in an electronic device.The data from the first participant can be identified for analysis asbeing from the first participant and/or as being from the firstmulti-participant survey. The system can comprise computer readableinstructions for accepting data from a second participant in a secondmulti-participant survey in the electronic device. The firstmulti-participant survey can be different from the secondmulti-participant survey. The data from the second participant can beidentified for analysis as being from the second participant and/or asbeing from the second multi-participant survey. The system can comprisecomputer readable instructions for aggregating the data from the firstparticipant and/or the data from the first multi-participant survey foranalysis, and aggregating the data from the second participant and/orthe data from the second multi-participant survey for analysis. In oneembodiment, the data from the first participant can comprise data fromthe first multi-participant survey, and the data from the secondparticipant can comprise data from the second multi-participant survey.In some cases, data from a plurality of multi-participant surveys (e.g.,greater than 10, greater than 100, greater than 1000, greater than10,000, greater than 100,000, or greater than 1,000,000) are aggregated;in some cases, data from a plurality of subjects (e.g., greater than 10,greater than 100, or greater than 1000, greater than 10,000, greaterthan 100,000, or greater than 1,000,000) are aggregated. In some cases,data from about 10 to about 100, about 100 to about 1000, about 1000 toabout 10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 multi-participant surveys are aggregated. In some cases, datafrom about 10 to about 100, about 100 to about 1000, about 1000 to about10,000, about 10,000 to about 100,000, or about 100,000 to about1,000,000 subjects are aggregated.

Electronic Devices

An electronic device used in the methods and systems described hereincan be adapted for use by a subject and/or third party (e.g., clinicalstaff) for viewing and/or inputting information. In one embodiment, theelectronic device is a portable electronic device. The portableelectronic device can be a handheld electronic device. The handhelddevice can be small enough to put into a pocket or purse. The handheldelectronic device can be, e.g., a phone and/or personal digitalassistant (PDA), cell phone, smartphone, mobile internet device,enterprise digital assistant, data capture mobile device, batchterminal, portable media player, feature phone, personal navigationdevice, Palm device (e.g., Palm Pilot, Palm TX), Pocket PC (WindowsMobile Classic device), or pager.

In one embodiment, the handheld electronic device is a smartphone. Thesmartphone can be manufactured by, e.g., Acer, Apple, Asus, AT&T,Blackberry, BLU products, Casio Inc., Dell Inc., Garmin-Asus,Hewlett-Packard (HP), HTC, Huawei Technologies col, Ltd., Kyocera, LG,Motorola, Nokia, Palm, Pantech & Curitel, Pharos, Samsung, ScoscheIndustries, Inc., Sharp, Sonim Technologies, Sony Ericsson, Sprint,Audiovox/UTStarcom, ZTE, or ZyXEL. The smartphone can comprise anoperating system, and the operating system can be, e.g., Android(Google), Windows Mobile (Microsoft), Windows Phone (Microsoft), Symbian(Nokia), Blackberry OS (RIM), iOS (Apple), or a Linux-based system,e.g., Maemo, or MeeGo.

In one embodiment, the electronic device is an iPhone, iPhone 4S, iPhone4, iPhone 3GS, iPhone 5, Sharp FX Plus, Palm Pixi Plus, HTC Status, LGPhoenix, Pantech Crossover, Samsung Captivate, Impulse 4G, Samsung Focu,Motorola Atrix, Sony Ericsson Xperia, HTC Inspire, Samsung Infuse, HTCHD7S, LG Thrill, Samsung Galaxy S II, HP iPAQ, HP iPAQ smartphone, HPiPAQ PDA, Nokia E7-00, Nokia E6-00, Nokia X3-02, Nokia C3-01, BlackBerryBold, Blackberry 9850, Blackberry Torch, Blackberry Curve, BlackBerryPearl, Samsung Stratosphere, HTC Rhyme, Motorola Droid Bionic, PantechBreakout, LG Enlighten, Motorola Droid, LG Revolution, etc.

The electronic device used in the methods and systems described hereincan be a computer. The computer can be, e.g., a personal computer,minicomputer, mainframe, multiprocessor system, network computer,processor-based electronic device, desktop computer, laptop computer, PCcomputer, Macintosh computer, notebook computer, netbook computer,e-reader, tablet computer, or tablet PC. In one embodiment, theelectronic device is a tablet computer. The tablet computer can be,e.g., an iPad or iPad 2. The computer can comprise an operating system.The operating system (OS) for the computer can be, e.g., Android, iOS,Linux, Mac OS X, Microsoft Windows, or Microsoft Windows XP. Theoperating system can be a real-time, multi-user, single-user,multi-tasking, single tasking, distributed, or embedded.

The electronic device can have one or more visual, audible, or tactilefeatures for communicating with the user or subject. For example, theelectronic device can communicate with a user by, e.g., vibration,e-mail, text messaging, voice mail, phone call, or print out. Theelectronic device can comprise pre-defined alerts that can remind a userto enter data into the electronic device. The electronic device can beconfigured to communicate with a user, by text or audibly, in one ormore of a number of different languages, e.g., English, Spanish, Welsh,Scots Gaelic, German, French, Italian, Swedish, Castilian Spanish,Catalan, Galician, Basque, Portuguese, Polish, Arabic, Russian, Hindi,Greek, Finnish, Danish, Czech, Croatian, Mandarin Chinese, Cantonese, orFlemish. Alerts provided by the electronic device can ensure at least60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% compliance with protocolrequirements for a multi-participant survey.

The electronic device can be configured to accept a response to multipledata collection options, e.g., scales, different questions type, e.g.,quality of life (QoL) assessments, etc. The electronic device can becapable of automatic software uploads.

The electronic device can also include one or more input and output(I/O) devices such as a mouse, game input device or controller, display,touch screen or other I/O device or devices in various combinations. Theelectronic device can comprise one or more other display and data inputfeatures that a user can use to interface with the electronic device. Aninput feature can be, e.g., a keyboard, mouse, touch-sensitive screen,tap-and-touch based interface, dial, button, trackball, light pen,digitizer pen, stylus or other pointing device, microphone, joystick, orvoice recognition feature. The electronic device can have a displayscreen with touch input and/or a miniature keyboard. A display screencan about, at least, less than, or more than 1, 2, 2.5, 3, 3.5, 4, 4.5,5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.1,12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19,19.5, or 20 inches in diameter, and can be in the landscape or portraitconfiguration. The electronic device can be connected to an outputdevice, such as a printer.

The electronic device can comprise other features, such as a digitalstill camera, digital video camera, calendar, speaker, clock, GPScapability, Bluetooth technology, or cloud computing capability. Theelectronic device can comprise a smart card reader, radio-frequencyidentification (RFID), or barcode. The electronic device can comprise awebbrowser, portable media player, camera, Wi-Fi, and mobile broadbandaccess.

In some cases, about, more than, less than, or at least 2, 3, 4, 5, 6,7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500,600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000,9000, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000,90,000, 100,000, 200,000, 300,000, 400,000, 500,000, 600,000, 700,000,800,000, 900,000, 1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000,6,000,000, 7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000,30,000,000, 40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000,90,000,000, or 100,000,000 electronic devices are used, or provided tosubjects in one or more multi-participant surveys. In some cases, about2 to about 10, about 10 to about 100, about 100 to about 1000, about1000 to about 10,000, about 10,000 to about 100,000, about 100,000 toabout 1,000,000, about 1,000,000 to about 10,000,000, about 10,000,000to about 100,000,000 electronic devices are used, or provided tosubjects in one or more multi-participant studies.

In some embodiments, the electronic device is not a portable electronicdevice. In some embodiments, the electronic device is not a handheldelectronic device. For example, the electronic device can be aworkstation.

The electronic device can be adapted to communicate with at least oneother computer via a wireless connection or via a wired connection,including the use of a modem and/or a network, such as a LAN or theInternet. Other networks can include, e.g. cellular communicationnetworks, Packet Data Networks (PDNs), 4 G network, 3 G communications,or Public Switched Telephone Network (PSTNs). The electronic device cancomprise integrated IEEE 802.11b/g.

Written instructions, in hardcopy or electronic form, can be provided toa user of an electronic device. The instructions can describe one ormore methods of operating the electronic device.

The electronic device can be a patient-reported outcome (PRO)instrument. The PRO instrument can be configured to satisfy Food andDrug Administration (FDA) guidelines for patient-reported outcomemeasures.

In one embodiment, digital rights management control (including controlof access rights and data flow paths) can be incorporated into thedevice to protect the privacy of subject data and/or medical historyinformation, e.g., in accordance with regulatory standards such as theHealth Insurance Portability and Accountability Act (HIPAA).

The electronic device can present one or more questions to a user. Theone or more questions can be presented audibly or on a display. The oneor more questions can be part of a multi-participant survey. In oneembodiment, only one question appears on the display at a time. Inanother embodiment, more than one question appears on the display at atime, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20 or more questions. In some embodiments, screen splitting can beused on the electronic device. In one embodiment, instructions for aquestionnaire can be placed on an introductory screen, and thenquestions are presented one per screen. In another embodiment, the textto a question is placed on one screen, and one or more response optionsare placed on a subsequent screen. In another embodiment, the sameinformation can be presented on multiple screens. In another embodiment,a screen can have a supplementary “pop-up.” In one embodiment, theinformation on a display of the electronic device can be presentedsimilar to a hard-copy paper. In another embodiment, a full A4 sizeelectronic device can allow reproduction of a paper page. In some cases,a user can adjust the display. For example, the user can adjust the textsize, brightness, contrast, text font, etc.

The electronic device can restrict entries by a user to only thoseentries that are in a valid range. In one embodiment, data are notaccepted by the device until all data are entered in the device. Thevalid range can be a numerical range. In some embodiments, entry of thedata is restricted based on time of day, time or week, time of year,drug administration history or schedule, or location of a subject (e.g.,based on use of GPS, for example).

The devices, systems, computer readable medium, and methods describedherein can be implemented in or upon a computer system. A computersystem can include various combinations of a central processor or otherprocessing device, an internal communication bus, various types ofmemory or storage media (RAM, ROM, EEPROM, cache memory, disk drives,etc.) for code and data storage, and one or more network interface cardsor ports for communication purposes. The devices, systems, and methodsdescribed herein may include or be implemented in software code, whichmay run on such computer systems or other systems. For example, thesoftware code can be executable by a computer system, for example, thatfunctions as the storage server or proxy server, and/or that functionsas a user's terminal device. During operation the code can be storedwithin the computer system. At other times, the code can be stored atother locations and/or transmitted for loading into the appropriatecomputer system. Execution of the code by a processor of the computersystem can enable the computer system to implement the methods andsystems described herein.

FIGS. 5 and 6 provide examples of functional block diagram illustrationsof computer hardware platforms. FIG. 5 shows an example of a network orhost computer platform, as can be used to implement a server orelectronic devices, according to an embodiment. FIG. 6 depicts acomputer or electronic device with user interface elements, as can beused to implement a personal computer, electronic device, or other typeof work station or terminal device according to an embodiment, althoughthe computer or electronic device of FIG. 6 can also act as a server ifappropriately programmed. The systems and methods described herein canbe implemented in or upon such computer hardware platforms in whole, inpart, or in combination. The systems and methods described herein,however, are not limited to use in such systems and can be implementedor used in connection with other systems, hardware or architectures. Themethods described herein can be implemented in computer software thatcan be stored in the computer systems, electronic devices, and serversdescribed herein.

A computer system, electronic device or server, according to variousembodiments, can include a data communication interface for packet datacommunication. The computer system, electronic device, or server canalso include a central processing unit (CPU), in the form of one or moreprocessors, for executing program instructions. The computer system,electronic device, or server can include an internal communication bus,program storage and data storage for various data files to be processedand/or communicated by the server, although the computer system orserver can receive programming and data via network communications. Thecomputer system, electronic device, or server can include varioushardware elements, operating systems and programming languages. Theelectronic device, server or computing functions can be implemented invarious distributed fashions, such as on a number of similar or otherplatforms.

The methods described herein can be implemented in mobile devices suchas mobile phones, mobile tablets and other mobile devices with variouscommunication capabilities including wireless communications, which mayinclude radio frequency transmission, infrared transmission or othercommunication technology. Thus, the hardware described herein mayinclude one or more transmitters and receivers for radio and/or othercommunication technology and/or interfaces to couple to andcommunication with communication networks.

The methods described herein can be implemented in computer softwarethat can be stored in the computer systems or electronic devicesincluding a plurality of computer systems and servers. These can becoupled over computer networks including the internet. Accordingly, anembodiment includes a network including the various system and devicescoupled with the network.

Further, various methods and architectures as described herein, such asthe various processes described herein or other processes orarchitectures, can be implemented in resources including computersoftware such as computer executable code embodied in a computerreadable medium, or in electrical circuitry, or in combinations ofcomputer software and electronic circuitry.

Aspects of the devices, systems, and methods described herein can beimplemented as functionality programmed into any of a variety ofcircuitry, including programmable logic devices (PLDs), such as fieldprogrammable gate arrays (FPGAs), programmable array logic (PAL)devices, electrically programmable logic and memory devices and standardcell-based devices, as well as application specific integrated circuits(ASICs). Some other possibilities for implementing aspects of thedevices, systems, and methods include: microcontrollers with memory,embedded microprocessors, firmware, software, etc. Furthermore, aspectsof the devices, systems, and methods can be embodied in microprocessorshaving software-based circuit emulation, discrete logic (sequential andcombinatorial), custom devices, fuzzy (neural network) logic, quantumdevices, and hybrids of any of the above device types. Of course theunderlying device technologies can be provided in a variety of componenttypes, e.g., metal-oxide semiconductor field-effect transistor (MOSFET)technologies like complementary metal-oxide semiconductor (CMOS),bipolar technologies like emitter-coupled logic (ECL), polymertechnologies (e.g., silicon-conjugated polymer and metal-conjugatedpolymer-metal structures), mixed analog and digital, etc.

The various functions or processes disclosed herein can be described asdata and/or instructions embodied in various computer-readable media, interms of their behavioral, register transfer, logic component,transistor, layout geometries, and/or other characteristics.Computer-readable media in which such formatted data and/or instructionscan be embodied include, but are not limited to, non-volatile storagemedia in various forms (e.g., optical, magnetic or semiconductor storagemedia, hard disk, optical disk, magneto-optical disk), volatile media(e.g., dynamic memories) and carrier waves that can be used to transfersuch formatted data and/or instructions through wireless, optical, orwired signaling media, transmission media (e.g., coaxial cables, copperwire, fibers optics) or any combination thereof. Examples of transfersof such formatted data and/or instructions by carrier waves include, butare not limited to, transfers (uploads, downloads, email, etc.) over theInternet and/or other computer networks via one or more data transferprotocols (e.g., HTTP, FTP, SMTP, etc.). Transmission media can includeacoustic, optical, or electromagnetic waves, e.g., such as thosegenerated during, e.g., radio frequency (RF) communications or infrareddata communications. When received within a computer system via one ormore computer-readable media, such data and/or instruction-basedexpressions of components and/or processes under the systems and methodscan be processed by a processing entity (e.g., one or more processors)within the computer system in conjunction with execution of one or moreother computer programs.

Processing, computing, calculating, determining, or the like, can referin whole or in part to the action and/or processes of a processor,computer or computing system, or similar electronic computing device,that manipulate and/or transform data represented as physical, such aselectronic, quantities within the system's registers and/or memoriesinto other data similarly represented as physical quantities within thesystem's memories, registers or other such information storage,transmission or display devices. Users can be individuals as well ascorporations and other legal entities. Furthermore, the processespresented herein are not inherently related to any particular computer,processing device, article or other apparatus. An example of a structurefor a variety of these systems will appear from the description herein.Embodiments of the invention are not described with reference to anyparticular processor, programming language, machine code, etc. A varietyof programming languages, machine codes, etc. can be used to implementthe teachings of the invention as described herein.

Authentication

Authentication of a user can be required before a user is able to use,or initiate application software of, an electronic device. Methods ofinitiating application software are described, e.g., in U.S. Pat. No.7,783,072. In one embodiment, a user can initiate application software,e.g., by double clicking a desktop icon on a computer system using amouse. A user identification module on a local system can begin toauthenticate the user of the software application. The useridentification module can comprise a login screen prompting user entryinto fields such as, e.g., a username, a password, and/or passcode. Ausername and password can be assigned to the user, or the user canchoose a username and password.

An electronic device can be configured to accept data from one or morespecific individuals. Identifying information can be required to beentered into an electronic device before the electronic device willaccept data from the individual. The identifying information cancomprise, e.g., date of birth, social security number, location ofbirth, mother's maiden name, grandparent's name, driver's licensenumber, or state identification number.

In one embodiment, asymmetric key cryptography (public-key cryptography)can be used to authenticate a user. The embodiment can employ a publickey and a private key, which can be related mathematically. Asymmetriccryptography differs from symmetric cryptography in that in asymmetriccryptography a user does not have to share the private key. A tokendevice, such as a smartcard or an eToken, can be used in such anexemplary public-key cryptography authentication. The use of such tokendevices and public-key cryptography to authenticate a user are wellknown in the field, and any such token device available can be used. Forexample, a user can log on and the user's public key and private key(which remains secret to the user) can encrypt the logon. The encryptioncan be transmitted to an external device, which also houses a copy ofthe user's public key. The external device can then decrypt theencryption, thereby verifying the user's identity, or authenticating theuser.

A smart card can be used to authenticate a user. A smart card can be thesize of a credit card, and can possess a processor and/or a memory thatcan exchange data with a computer system. A smart card can have anembedded Integrated Circuit (IC). The IC can be a logic circuit with itsassociated memories or a microcontroller with its associated memoriesand software, or a microcontroller with its associated memories andsoftware coupled to a custom circuit block or interface. In oneembodiment, a smart card can provide a processor and/or memory in asilicon-based integrated circuit. A smart card can include electronic oroptical interfaces to exchange data with a computer system and can bepowered by a battery or other power source.

In another embodiment, biometrics can be used to authenticate a user,e.g., either by providing the user's private key or both the private keyand password. Biometrics can include a method of verifying anindividual's identity based on a measurement of an individual's physicalfeature or repeatable actions where those features and/or actions areboth unique to that individual and measurable. Biometrics can includethe use of, e.g., voice, speech, fingerprint, retina, iris, handgeometry, facial recognition, handwritten signature, genetic material,or veins, nucleic acid (e.g., DNA or RNA), protein sample, and/or bloodsample. In one embodiment, an identification module can comprise abiometric recognition, such that the biometric recognition comprises theuser's username and passcode. In another embodiment, the biometricrecognition can comprise the user's username, and then the electronicdevice can prompt the user for a passcode.

In another embodiment, private and public keys and/or username andpassword can be periodically changed to prevent unauthorized users fromgaining access to the local system. A username or public key can also bedeactivated, such as if a token device is reported missing or stolen.

Requiring a username and passcode, or public and private key, toauthenticate a user can comply with the requirements for an electronicsignature under 21 C.F.R. Part 11, which states in relevant part thatelectronic signatures which are not based on biometrics shall employ atleast two distinct identification components, such as an identificationcode and password.

A username and password can be provided by the user to initially loginto an application on an electronic device. A local system can thentransmit the user-provided username and password to a userauthentication module on an external device. The external device can bea computer system, such as a personal computer, or can be a server. Theexternal device can comprise a database which comprises a plurality ofstored usernames and passcodes. The username and passcode can beassigned to a user upon account activation, or when a user firstinstalls the software application.

An electronic device can be provided to a site, e.g., a clinic,hospital, medical center, laboratory, etc. A plurality of participantscan communicate with the site. For example, the plurality ofparticipants can communicate with the site through in-person visits. Theplurality of participants can communicate with the site electronically.The electronic communication can be, e.g., an e-mail, a text, atelephone call, or a voice message. An electronic device can be providedto a participant, who can possess the electronic device for a period oftime (e.g., days, weeks, months, years, or decades).

An electronic device can communicate with other electronic devices, forexample, over a network. An electronic device can communicate with anexternal device (e.g., staging data repository) using a variety ofcommunication protocols. A set of standardized rules, referred to as aprotocol, can be used utilized to enable electronic devices tocommunicate. In one embodiment, the communications protocol used is HTTP(“Hypertext Transfer Protocol”). HTTP can be an application-levelprotocol used in connecting servers and users on the World-Wide Web(WWW). HTTP can be based on a request-response mechanism and can use TCP(“Transmission Control Protocol”) connections to transfer data. Inanother embodiment, HTTPS (“Hypertext Transfer Protocol Secure”), avariant of HTTP that can implement the SSL (“Secure Sockets Layer”)mechanism, is used. SSL can be a standard protocol for implementingcryptography and enabling secure transactions on the Web. SSL can usepublic key signatures and digital certificates to authenticate a serverand user and can provide an encrypted connection for the user and serverto exchange messages securely. When HTTPS is the protocol used, the URL(Uniform Resource Locator) defining the HTTPS request is directed to asecure port number instead of a default port number to which an HTTPrequest is directed. Other protocols can be used to transfer data, forexample without limitation, FTP or NFS.

An electronic device can be connected to a staging data repositoryand/or server through, e.g., a network. A network can be a small systemthat is physically connected by cables or via wireless communication (alocal area network or “LAN”). An electronic device can be a part ofseveral separate networks that are connected together to form a largernetwork (a wide area network or “WAN”). Other types of networks of whichan electronic device can be a part of include the internet, telcomnetworks, intranets, extranets, wireless networks, and other networksover which electronic, digital and/or analog data can be communicated.

Communication between the electronic device and an external device,e.g., staging data repository, can be accomplished wirelessly. Suchwireless communication can be Bluetooth or RTM technology. In oneembodiment, a wireless connection can be established using exemplarywireless networks such as cellular, satellite, or pager networks, GPRS,or a local data transport system such as Ethernet or token ring over alocal area network.

A user authentication module can initiate a request to, or query, adatabase to detect the transmitted username. If the username exists inthe database, the user authentication module can query the database forthe passcode or password associated with the username and compare it tothe transmitted passcode. If the transmitted passcode is the same as thepasscode in the database, the user can be successfully authenticated andthe software application on the local system will initialize. If thetransmitted username is not found in the database or if the transmittedpasscode does not match the stored passcode, the software applicationwill not initialize and the user can again be prompted to provide ausername and passcode by any of the methods described herein. There canbe a limited number of times an authentication can be attempted before auser is locked out of the system. Requiring a passcode to authenticate auser can help prevent fraudulent attempts to login under a user'susername and also creates a record keeping or tracking system of when auser attempts to login and the identity of the user.

An electronic device can be in communication with one or more servers.The one or more servers can be an application server, a catalog server,a communication server, an access server, a link server, a data server,a staging server, a database server, a member server, a fax server, agame server, a pedestal server, a micro server, a name server, a remoteaccess server (RAS), a live access server (LAS), a network access server(NAS), a home server, a proxy server, a media server, a nym server,network server, a sound server, file server, mail server, print server,a standalone server, or a web server. A server can be a computer.

One or more databases can be used to store information from anelectronic device. The databases can be organized using data structures(e.g., trees, fields, arrays, tables, records, lists) included in one ormore memories or storage devices.

Entering and Recording Data

In one embodiment, an electronic device can be configured to accept datafrom a plurality of multi-participant surveys. In another embodiment, anelectronic device configured to receive data from a plurality ofmulti-participant surveys can be temporarily configured to receive datafrom a single multi-participant survey. For example, if an electronicdevice is configured to receive data from two multi-participant surveys,the device can be temporarily configured such that a first subject in afirst multi-participant survey is only able to enter data regarding thefirst multi-participant survey in the device. In one embodiment, it istemporarily not possible to enter data from a second multi-participantsurvey into the electronic device. The electronic device can appear tothe first subject to be able to only accept data for a singlemulti-participant study when the device is actually configured toreceive data for two or more multi-participant surveys. In some cases,the electronic device is configured to receive data from a plurality ofmulti-participant surveys (e.g., about, more than, less than, or atleast 10, 100, 1000, 10,000, 100,000, 1,000,000, 10,000,000, or100,000,000). In some cases, the subject possessing or generating datadoes not enter the data into an electronic device; rather, another partycan enter the data into the electronic device for the subject or onbehalf of the subject.

After a first subject in a first multi-participant survey enters datainto an electronic device, the electronic device can be provided to asecond subject in a second multi-participant survey, and the secondsubject in the second multi-participant survey can enter data into theelectronic device. The electronic device can be temporarily configuredto accept data from only the second subject in the secondmulti-participant survey. In some cases, the subject possessing orgenerating data does not enter the data into an electronic device;rather, another party can enter the data into the electronic device forthe subject or on behalf of the subject.

In one embodiment, the methods described herein comprise recording datafrom a first participant in a first multi-participant survey and datafrom a second participant in a second multi-participant survey on anelectronic device. In another embodiment, a computer readable mediumprovided herein comprises instructions that, when executed by a computersystem, cause the computer system to record data from a firstparticipant in a first multi-participant survey and data from a secondparticipant in a second multi-participant survey on an electronicdevice. In another embodiment, a system provided herein comprisescomputer readable instructions for recording data from a firstparticipant in a first multi-participant survey and data from a secondparticipant in a second multi-participant survey on an electronicdevice.

Entering, recording, aggregating, and identifying data can make use ofhardware elements including circuitry, software elements includingcomputer code stored on a tangible, machine-readable medium or acombination of hardware and software elements. Software can include,e.g., device drivers, development tools, firmware, application software,or operating systems. An input feature described herein can be used toinput data, e.g., a keyboard, mouse, touch-sensitive screen,tap-and-touch based interface, dial, button, trackball, light pen,digitizer pen, stylus or other pointing device, microphone, joystick, orvoice recognition feature. The electronic device can have a displayscreen with touch input and/or a miniature keyboard. In some cases, dataare entered into a device in real-time (as the data are generated). Datacan be entered into a device after an event.

Data can be identified for analysis by one or more methods. Data can beidentified for analysis by individual study (e.g., specific clinicaltrial), type of study (e.g., clinical trial, consumer survey, politicalpoll), organizer of a study (e.g., academician, college, university,laboratory, hospital, pharmaceutical company, political party, politicalaction committee, non-profit organization), by individual subject, bycharacteristics of one or more subjects (e.g., age, gender, height,weight, body mass index, blood pressure, blood sugar level, cholesterollevel, nationality, ethnicity, race, occupation, residence, citizenship,criminal record, political party affiliation, annual income, highesteducation level (no high school, some high school, high school graduate,two-year college degree, four-year college degree, graduate degree,doctoral degree, medical degree, law degree), pharmaceutical usage,exercise level, or smoking rate). Data can be electronically “tagged”with one or more of these types of pieces of information in order to beidentified for analysis. Data can be identified for analysis usingmetadata.

Staging Data Repository

In one embodiment, an electronic device provided herein is incommunication with a staging data repository. The staging datarepository can be used to store data from a plurality ofmulti-participant surveys. In one embodiment, the staging datarepository is a server. The staging data repository can communicate withone or more other electronic devices. The staging data repository cancomprise data from a plurality of multi-participant surveys. The stagingdata repository can receive data uploaded from an electronic device.Subject specific and multi-participant survey specific data can becopied from the staging data repository to an appropriate study datarepository (see, e.g., FIG. 2). The staging data repository can behosted on PC-based server software. The staging data repository can bepart of a Web-based system.

In some cases, a staging data repository can receive data from about,more than, less than, or at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30,40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900,1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10,000, 20,000,30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000,200,000, 300,000, 400,000, 500,000, 600,000, 700,000, 800,000, 900,000,1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000, 6,000,000,7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000, 30,000,000,40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000, 90,000,000,or 100,000,000 electronic devices. In some cases, a staging datarepository can receive data from about 2 to about 10, about 10 to about100, about 100 to about 1000, about 1000 to about 10,000, about 10,000to about 100,000, about 100,000 to about 1,000,000, about 1,000,000 toabout 10,000,000, about 10,000,000 to about 100,000,000 electronicdevices.

In some cases, a staging data repository can receive data from about,more than, less than, or at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30,40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900,1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10,000, 20,000,30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000,200,000, 300,000, 400,000, 500,000, 600,000, 700,000, 800,000, 900,000,1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000, 6,000,000,7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000, 30,000,000,40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000, 90,000,000,or 100,000,000 multi-participant surveys. In some cases, a staging datarepository can receive data from about 2 to about 10, about 10 to about100, about 100 to about 1000, about 1000 to about 10,000, about 10,000to about 100,000, about 100,000 to about 1,000,000, about 1,000,000 toabout 10,000,000, about 10,000,000 to about 100,000,000multi-participant surveys.

In some cases, a staging data repository can receive data from about,more than, less than, or at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30,40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900,1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10,000, 20,000,30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000,200,000, 300,000, 400,000, 500,000, 600,000, 700,000, 800,000, 900,000,1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000, 6,000,000,7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000, 30,000,000,40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000, 90,000,000,or 100,000,000 subjects, e.g., patients. In some cases, a staging datarepository can receive data from about 2 to about 10, about 10 to about100, about 100 to about 1000, about 1000 to about 10,000, about 10,000to about 100,000, about 100,000 to about 1,000,000, about 1,000,000 toabout 10,000,000, or about 10,000,000 to about 100,000,000 subjects,e.g., patients.

In one embodiment, a method provided herein comprises transmitting dataidentified as being from a first participant in a firstmulti-participant survey to a staging data repository and transmittingdata identified as being from a second participant in a secondmulti-participant survey to the staging data repository. The data can betransmitted as a data stream. In another embodiment, a method providedherein comprises transmitting data identified as being from a firstmulti-participant survey to a staging data repository and transmittingdata identified as being from a second multi-participant survey to thestaging data repository. Data from a plurality of multi-participantsurveys can be transmitted to the staging data repository. Data from aplurality of participants can be transmitted to the staging datarepository.

In another embodiment, a computer readable medium provided hereincomprises sequences of instructions, which, when executed by a computersystem, cause the computer system to transmit data identified as beingfrom a first participant in the first multi-participant survey to astaging data repository and transmit data identified as being from asecond participant in the second multi-participant survey to the stagingdata repository. In another embodiment, a computer readable mediumprovided herein comprises sequences of instructions, which, whenexecuted by a computer system, cause the computer system to transmit thedata identified as being from a first multi-participant survey to astaging data repository and transmit data identified as being from asecond multi-participant survey to the staging data repository. Datafrom a plurality of multi-participant surveys can be transmitted to thestaging data repository. Data from a plurality of participants can betransmitted to the staging data repository.

In another embodiment, a system provided herein comprises computerreadable instructions for transmitting data identified as being from afirst participant in a first multi-participant survey to a staging datarepository and transmitting data identified as being from a secondparticipant in the second multi-participant survey to the staging datarepository. In another embodiment, a system provided herein comprisescomputer readable instructions for transmitting data identified as beingfrom a first multi-participant survey to a staging data repository andtransmitting data identified as being from a second multi-participantsurvey to the staging data repository. Data from a plurality ofmulti-participant surveys can be transmitted to the staging datarepository. Data from a plurality of participants can be transmitted tothe staging data repository.

In some cases, a plurality of staging data repositories are provided,e.g., about, more than, less than, or at least 2, 3, 4, 5, 6, 7, 8, 9,10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, 600, 700,800, 900, 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10,000,20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000,200,000, 300,000, 400,000, 500,000, 600,000, 700,000, 800,000, 900,000,1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000, 6,000,000,7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000, 30,000,000,40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000, 90,000,000,or 100,000,000. In some cases, the number of staging data repositoriesprovided is about 2 to about 10, about 10 to about 100, about 100 toabout 1000, about 1000 to about 10,000, about 10,000 to about 100,000,about 100,000 to about 1,000,000, about 1,000,000 to about 10,000,000,or about 10,000,000 to about 100,000,000.

Study Data Repositories

In another embodiment, a staging data repository is in electroniccommunication with a plurality of study data repositories. A study datarepository can be used to store data specific to an individual and/orspecific to a multi-participant study (e.g., clinical trial). Theplurality of study data repositories can comprise a first study datarepository and a second study data repository. The plurality of studydata repositories can comprise about, at least, more than, or less than2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39,40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75,76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93,94, 95, 96, 97, 98, 99, 100, 200, 300, 400, 500, 600, 700, 800, 900,1000, 5000, 10,000, 100,000, 1,000,000, 10,000,000, or 100,000,000 studydata repositories. The plurality of study data repositories can compriseabout 2 to about 1000, about 2 to about 500, about 2 to about 100, about2 to about 50, about 2 to about 25, about 2 to about 10, about 2 toabout 5, about 10 to about 1000, about 10 to about 500, about 10 toabout 100, about 10 to about 50, about 10 to about 25, or about 10 toabout 15 study data repositories. The number of study data repositoriescan be about 100 to about 1000, about 1000 to about 10,000, about 10,000to about 100,000, about 100,000 to about 1,000,000, about 1,000,000 toabout 10,000,000, or about 10,000,000 to about 100,000,000. In someembodiments, a staging data repository and one or more study datarepositories can share the same master database. Two or more datarepositories can be synchronized by updating all or part of a study datarepository to match a source data repository.

In one embodiment, a method provided herein comprises transferring, fromthe staging data repository, the data identified as being from a firstparticipant in a first multi-participant survey to a first study datarepository and data identified as being from a second participant in asecond multi-participant survey to the second study data repository. Inanother embodiment, a method provided herein comprises transferring,from a staging data repository, data identified as being from a firstmulti-participant survey to a first study data repository and dataidentified as being from a second multi-participant survey to a secondstudy data repository.

In some cases, data collected from about, more than, less than, or atleast 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100,200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000,6000, 7000, 8000, 9000, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000,70,000, 80,000, 90,000, 100,000, 200,000, 300,000, 400,000, 500,000,600,000, 700,000, 800,000, 900,000, 1,000,000, 2,000,000, 3,000,000,4,000,000, 5,000,000, 6,000,000, 7,000,000, 8,000,000, 9,000,000,10,000,000, 20,000,000, 30,000,000, 40,000,000, 50,000,000, 60,000,000,70,000,000, 80,000,000, 90,000,000, or 100,000,000 electronic devicescan be transferred from a staging data repository. In some cases, datacollected from about 2 to about 10, about 10 to about 100, about 100 toabout 1000, about 1000 to about 10,000, about 10,000 to about 100,000,about 100,000 to about 1,000,000, about 1,000,000 to about 10,000,000,or about 10,000,000 to about 100,000,000 electronic devices can betransferred from a staging data repository.

In some cases, data collected from about, more than, less than, or atleast 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100,200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000,6000, 7000, 8000, 9000, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000,70,000, 80,000, 90,000, 100,000, 200,000, 300,000, 400,000, 500,000,600,000, 700,000, 800,000, 900,000, 1,000,000, 2,000,000, 3,000,000,4,000,000, 5,000,000, 6,000,000, 7,000,000, 8,000,000, 9,000,000,10,000,000, 20,000,000, 30,000,000, 40,000,000, 50,000,000, 60,000,000,70,000,000, 80,000,000, 90,000,000, or 100,000,000 multi-participantsurveys can be transferred from a staging data repository. In somecases, data collected from about 2 to about 10, about 10 to about 100,about 100 to about 1000, about 1000 to about 10,000, about 10,000 toabout 100,000, about 100,000 to about 1,000,000, about 1,000,000 toabout 10,000,000, or about 10,000,000 to about 100,000,000multi-participant surveys can be transferred from a staging datarepository.

In some cases, data collected from about, more than, less than, or atleast 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100,200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000,6000, 7000, 8000, 9000, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000,70,000, 80,000, 90,000, 100,000, 200,000, 300,000, 400,000, 500,000,600,000, 700,000, 800,000, 900,000, 1,000,000, 2,000,000, 3,000,000,4,000,000, 5,000,000, 6,000,000, 7,000,000, 8,000,000, 9,000,000,10,000,000, 20,000,000, 30,000,000, 40,000,000, 50,000,000, 60,000,000,70,000,000, 80,000,000, 90,000,000, or 100,000,000 subjects, e.g.,patients can be transferred from a staging data repository. In somecases, data collected from about 2 to about 10, about 10 to about 100,about 100 to about 1000, about 1000 to about 10,000, about 10,000 toabout 100,000, about 100,000 to about 1,000,000, about 1,000,000 toabout 10,000,000, or about 10,000,000 to about 100,000,000 subjects,e.g., patients can be transferred from a staging data repository.

In another embodiment, a computer readable medium provided hereincomprises sequences of instructions, which, when executed by a computersystem, cause the computer system to transfer, from the staging datarepository, data identified as being from a first participant in a firstmulti-participant survey to a first study data repository and the dataidentified as being from a second participant in a secondmulti-participant survey to a second study data repository. In anotherembodiment, a computer readable medium provided herein comprisessequences of instructions, which, when executed by a computer system,cause the computer system to transfer, from a staging data repository,data identified as being from a first multi-participant survey to afirst study data repository and data identified as being from a secondmulti-participant survey to a second study data repository.

In another embodiment, a system provided herein comprises computerreadable instructions for transferring, from a staging data repository,data identified as being from a first participant in the firstmulti-participant survey to a first study data repository and dataidentified as being from a second participant in a secondmulti-participant survey to a second study data repository. In anotherembodiment, a system provided herein comprises computer readableinstructions for transferring, from a staging data repository, dataidentified as being from a first multi-participant survey to a firststudy data repository and data identified as being from a secondmulti-participant survey to a second study data repository.

One or more of the plurality of study data repositories can be locked.Locking a study data repository can prevent data in a staging datarepository from being transferred to the locked study data repository(see e.g., FIG. 3). The number of study data repositories that can belocked can be about, at least, more than, or less than 2, 3, 4, 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97,98, 99, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 5000, 10,000,100,000, 1,000,000, 10,000,000, or 100,000,000 study data repositories.The number of study data repositories that can be locked can be about 2to about 1000, about 2 to about 500, about 2 to about 100, about 2 toabout 50, about 2 to about 25, about 2 to about 10, about 2 to about 5,about 10 to about 1000, about 10 to about 500, about 10 to about 100,about 10 to about 50, about 10 to about 25, or about 10 to about 15study data repositories. The number of study data repositories that canbe locked can be about 100 to about 1000, about 1000 to about 10,000,about 10,000 to about 100,000, about 100,000 to about 1,000,000, about1,000,000 to about 10,000,000, or about 10,000,000 to about 100,000,000.In some cases, all available study data repositories are locked. In somecases, no study data repositories are locked.

In one embodiment, a method provided herein comprises locking at leastone of the plurality of study data repositories. In another embodiment,a computer readable medium provided herein comprises sequences ofinstructions, which, when executed by a computer system, cause thecomputer system to lock at least one of the plurality of study datarepositories. In another embodiment, a system provided herein comprisescomputer readable instructions for locking at least one of a pluralityof study data repositories.

One or more study data repositories can be added or removed fromcommunication with a staging data repository. The number of study datarepositories that can be added or removed from communication with astaging data repository can be about, at least, more than, or less than2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39,40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75,76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93,94, 95, 96, 97, 98, 99, 100, 200, 300, 400, 500, 600, 700, 800, 900,1000, 5000, 10,000, 100,000, 1,000,000, 10,000,000, or 100,000,000 studydata repositories. The number of study data repositories that can beadded or removed from communication with a staging data repository canbe about 2 to about 1000, about 2 to about 500, about 2 to about 100,about 2 to about 50, about 2 to about 25, about 2 to about 10, about 2to about 5, about 10 to about 1000, about 10 to about 500, about 10 toabout 100, about 10 to about 50, about 10 to about 25, or about 10 toabout 15 study data repositories. The number of study data repositoriesthat can be added or removed from communication with a staging datarepository can be about 100 to about 1000, about 1000 to about 10,000,about 10,000 to about 100,000, about 100,000 to about 1,000,000, about1,000,000 to about 10,000,000, or about 10,000,000 to about 100,000,000.

In one embodiment, a method provided herein comprises adding or removingone or more study data repositories from communication with a stagingdata repository. In another embodiment, a computer readable mediumprovided herein comprises sequences of instructions which, when executedby a computer system, cause the computer system to add or remove one ormore study data repositories from communication with a staging datarepository. In another embodiment, a system provided herein comprisescomputer readable instructions for adding or removing at least one studydata repository from communication with a staging data repository.

In one embodiment, data intended for a first study data repository canbe transferred from a staging data repository to an unintended studydata repository. The data transferred to the unintended study datarepository can be transferred directly from the unintended study datarepository to the intended first study data repository (see e.g., FIG.4). The data transferred to the unintended study data repository neednot be transferred back to the staging data repository beforetransferring the data to the intended study data repository.

In one embodiment, a method provided herein comprises identifying dataas being from a first participant in a first multi-participant studythat is transferred from a staging data repository to the second studydata repository (i.e., data that is transferred to an unintended studydata repository), and transferring, from the second study datarepository to a first study data repository, the data identified asbeing from the first participant in the first multi-participant studythat was transferred from the staging data repository to the secondstudy data repository. In another embodiment, a computer readable mediumprovided herein comprises sequences of instructions, which, whenexecuted by a computer system, cause the computer system to identifydata as being from a first participant in a first multi-participantstudy that is transferred from a staging data repository to the secondstudy data repository (i.e., data that is transferred to an unintendedstudy data repository), and transferring, from the second study datarepository to a first study data repository, the data identified asbeing from the first participant in the first multi-participant studythat was transferred from the staging data repository to the secondstudy data repository. In another embodiment, a system is providedherein comprising computer readable instructions for identifying data asbeing from a first participant in a first multi-participant study thatis transferred from a staging data repository to the second study datarepository (i.e., data that is transferred to the unintended study datarepository), and transferring, from the second study data repository toa first study data repository, the data identified as being from thefirst participant in the first multi-participant study that wastransferred from the staging data repository to the second study datarepository.

Computer Readable Medium and Systems

A computer readable medium can comprise instructions recorded on thecomputer readable medium suitable for use in an electronic device, e.g.,a computer, computer network server, portable electronic device, orelectronic device described herein. Computer readable media can beconfigured to include data or computer executable instructions formanipulating data. The computer executable instructions can include datastructures, objects, programs, routines, or other program modules thatcan be accessed by a processing system, such as one associated with ageneral purpose computer capable of performing different functions orone associated with a special purpose computer capable of performing alimited number of functions. Computer executable instructions can causea processing system to perform a particular function or group offunctions and are examples of program codes for implementing steps formethods disclosed herein. A particular sequence of executableinstructions can provide an example of corresponding acts that can beused to implement such steps. Computer readable media includes, e.g., ahard disk, diskette, random-access memory (“RAM”), read-only memory(“ROM”), programmable read-only memory (“PROM”), erasable programmableread-only memory (“EPROM”), electrically erasable programmable read-onlymemory (“EEPROM”), compact disk read-only memory (“CD-ROM”), CD±R,CD±RW, DVD, DVD±RW, DVD±R, DVD-RAM, HD DVD, HD DVDR, HD DVD±RW, HDDVD±RAM, Blu-ray Disc, optical or magnetic storage medium, paper tape,punch cards, optical mark sheets or any other device that is capable ofproviding data or executable instructions that can be accessed by aprocessing system. Computer readable medium are described, e.g., in U.S.Pat. No. 7,783,072.

Computer code devices can include, e.g., scripts, dynamic link libraries(DLLs), interpretable programs, Java classes and applets, Common ObjectRequest Broker Architecture (COBRA), or complete executable programs.

Systems provided herein can comprise one or more electronic devices thatare in electronic communication. The one or more electronic devices canbe connected by a wireless and/or wired connection.

In one aspect, a system for managing data from a plurality ofmulti-participant surveys is provided. The system can comprise anelectronic device. The electronic device can comprise logic forreceiving data from a first participant in a first multi-participantsurvey, wherein the data from the first participant are identified foranalysis as being from the first participant or as being from the firstmulti-participant survey. The electronic device can comprise logic forreceiving data from a second participant in a second multi-participantsurvey into the electronic device, wherein the first multi-participantsurvey is different from the second multi-participant survey, andwherein the data from the second participant are identified for analysisas being from the second participant or as being from the secondmulti-participant survey. The electronic device can comprise logic foraggregating the data from the first participant or the data from thefirst multi-participant survey for analysis. The electronic device cancomprise logic for aggregating the data from the second participant orthe data from the second multi-participant survey for analysis. Theelectronic device can comprise storage adapted to store the aggregateddata from the first participant or the data from the firstmulti-participant survey and the aggregated data from the secondparticipant or the data from the second multi-participant survey. Thesystem can comprise a staging data repository. The staging datarepository can comprise an interface for communication with saidelectronic device. The staging data repository can comprise logic forreceiving data from said electronic device through said communicationinterface. The staging data repository can comprise storage adapted toreceive the aggregated data from the first participant or the data fromthe first multi-participant survey and the aggregated data from thesecond participant or the data from the second multi-participant survey.The system can comprise a plurality of study data repositories. Theplurality of study data repositories can comprise an interface forcommunication with said staging data repository. The plurality of studydata repositories can comprise logic for receiving data from saidstaging data repository. The plurality of study data repositories cancomprise logic for processing data from said staging data repository.The logic used in any component in the system can comprise electroniccircuitry, computer program code, or electronic circuitry and computerprogram code.

Multi-Participant Survey

Data from a plurality of multi-participant surveys can be entered intoan electronic device described herein. A multi-participant survey canbe, e.g., a clinical trial. The clinical trial can be, e.g., a treatmenttrial, a prevention trial, a diagnostic trial, a screening trial, or aquality of life trial. The multi-participant survey can be a phase of aclinical trial. The phase of a clinical-trial can be, e.g., Phase 0,Phase 1, Phase 2, Phase 3, or Phase 4. Phase 0 can be an exploratorystudy involving very limited human exposure to a drug, with notherapeutic or diagnostic goals (for example, screening studies,microdose studies). The multi-participant survey can assess the safetyand efficacy of a drug, device, or treatment. Phase 1 can be a studyconducted with healthy volunteers and that emphasizes safety. The goalof a Phase 1 study can be to find out what a drug's most frequent andserious adverse events can be and to determine how the drug can bemetabolized and excreted. Phase 2 can be a study that gatherspreliminary data on effectiveness (e.g., whether a drug works in peoplewho have a certain disease or condition). For example, participantsreceiving a drug may be compared with similar participants receiving adifferent treatment, e.g., an inactive substance (placebo) or adifferent drug. Safety can continue to be evaluated, and short-termadverse events can be studied. Phase 3 can be a study that gathers moreinformation about safety and effectiveness by studying differentpopulations and different dosages and by using a drug in combinationwith other drugs. Phase 4 can be a study occurring after FDA hasapproved a drug for marketing. These studies can include post-marketrequirement and commitment studies that can be required of, or agreedto, by a sponsor of a clinical trial. These studies can be used togather additional information about a drug's safety, efficacy, oroptimal use. The multi-participant survey can be an Expanded AccessStudy. The clinical trial can be sponsored by, e.g., one or morephysicians, medical institutions, foundations, voluntary groups,pharmaceutical companies, National Institutes of Health (NIH), theDepartment of Defense (DOD), or the Department of Veteran's Affairs(VA). The clinical trial can take place, e.g., at a hospital,university, doctor's office, or community clinic.

In another embodiment, a multi-participant survey is a poll, e.g., anexit poll, e.g., a poll conducted of voters after the voters vote in alocal, state, or federal election. The multi-participant survey can bean exit poll for an election in the United States or in another country.The exit poll can contain one or more questions regarding one or morecandidates for president, U.S. senator, U.S. representative, governor,state senator, state representative, mayor, city council member, etc. Insome cases, the poll is a poll conducted before an election (e.g.,opinion poll), e.g., about, more than, less than, or at least 1 week, 2weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12months, 13 months, 14 months, 15 months, 16 months, 17 months, 18months, 19 months, 20 months, 21 months, 22 months, 23 months, 24months, 30 months, 36 months, 42 months, or 48 months before anelection. The opinion poll can ask whom a potential voter plans to votefor in an election. The poll can be conducted by a private company,e.g., media organization (e.g., newspaper, television station,television broadcast company, radio station, or online newspaper ormagazine). In some cases, the poll can be conducted by a politicalparty, e.g., Republican Party, Democratic Party, Libertarian Party,Green Party, or Constitution Party. In some cases, the pool is conductedby a political action committee (PAC).

In some cases, the poll can be a poll of coaches, members of the media,or others for the purpose of ranking athletic teams, e.g., NationalCollegiate Athletic Association (NCAA) (Division I, II, or III),National Association of Intercollegiate Athletics (NAIA), high school(state and national level) basketball teams, football teams, volleyballteams, cross country teams, lacrosse teams, tennis teams, golf teams,gymnastics teams, wrestling teams, etc.

In another embodiment, a multi-participant survey can be a customerservice survey. The customer-service survey can comprise questionsrelating to timeliness of service or quality of service. The service canbe associated with a restaurant, lodging facility (e.g., hotel, motel,inn, lodge, or hostel), department store, electronics store, computersupport, automobile repair, purchase from the Internet, or academicinstitution (e.g., high school, college, university, graduate school,law school, or medical school), tourist location, cruise, groupvacation, home repair, spa, resort, etc.

The multi-participant survey can be a market survey. The market surveycan ask questions regarding competitors, market structure, governmentregulations, economic trends, and/or technological advances.

The multi-participant survey can be used for advertising research. Theadvertising research can comprise analyzing audience levels ofattention, brand linkage, motivation, entertainment, communication, flowof attention, and flow of emotion. The multi-participant survey cancomprise ad tracking (e.g., periodic or continuous in-market research tomonitor a brand's performance using measures such as brand awareness,brand preference, and product usage). In some cases, themulti-participant survey can comprise brand equity research (e.g., howfavorably do consumers view a brand?), brand association research (e.g.,what do consumers associate with a brand?), brand attribute research(e.g., what are the key traits that describe the brand?), brand nametesting (e.g., what do consumers feel about the names of products?). Themulti-participant survey can comprise concept testing (e.g., to test theacceptance of a concept by target consumers); “coolhunting” (e.g., tomake observations and predictions in changes of new or existingculture); buyer decision process research (e.g., to determine whatmotivates a subject to buy and what decision-making process they use);customer satisfaction research (e.g., quantitative or qualitativestudies that yield an understanding of a customer's satisfaction with atransaction); demand estimation (e.g., to determine the approximatelevel of demand for a product); distribution channel audits (e.g., toassess distributors' and retailer's attitudes toward a product, brand,or company); mystery consumer or mystery shopping (e.g., a subjectanonymously contacts a salesperson and indicates he or she is shoppingfor a product; the subject can then record one or more aspects of theshopping experience); price elasticity testing (e.g., to determine howsensitive customers are to price changes); sales forecasting (e.g., todetermine the expected level of sales given the level of demand, e.g.,with respect to other factors, e.g., advertising expenditure, salespromotion, etc.); segmentation research (e.g., to determine demographic,psychographic, and behavioral characteristics of potential buyers); ortest marketing (e.g., a small-scale product launch to test likelyacceptance in a wider market).

In another embodiment, a multi-participant survey can be a productsurvey. The product can be, e.g., an automobile, an appliance (e.g., arefrigerator, an oven, a microwave, a stove, a dishwasher, a washingmachine, a dryer), toy, clothing, shoes, food, cleaning product,utensil, carpet, electronic device (e.g., computer, television, audiosystem), yard equipment (e.g., mower), or athletic event. The productsurvey can inquire about a consumer's opinions regarding a product, aconsumer's opinion of the brand of the product, or a consumer'sawareness of a product, or how a consumer compares a product to acompetitor's product. The product survey can assess effects of marketingefforts. A product survey can assess a consumer's level of satisfactionwith a product.

In another embodiment, a multi-participant survey can be a publicopinion survey or poll. The public opinion survey or poll can comprisequestions regarding the economy, public health, health care, consumerconfidence, public policy, opinions toward one or more officeseekers,voting behavior, attitudes toward economic, social, or politicalpriorities, attitudes toward economic development, issues relevant to aparticular geographic area (e.g., state, county, city, or neighborhood),attitudes toward ballot initiatives, attitudes towards foreign affairs,attitudes towards the military, attitudes towards conflicts (e.g.,battles, wars), attitudes towards education (primary, secondary,post-secondary, graduate), political events, work, family life, thepress, the media, economic conditions, ethical issues, scientificresearch, underage drinking, charitable giving, federal electedofficials, state elected officials, quality of life, quality of life ina specific geographic area (e.g., state, county, city, or neighborhood),attitudes towards political candidates and election issues, ethical andpublic policy implications of scientific discovery, attitudes on crime,lotteries, race relations, underage drinking, charitable giving, healthcare privacy, privacy, drug abuse, environment, immigration; statewidereferenda, social issues, performance of federal and state electedofficials, environment, education, fiscal policy, local, state, orfederal government response to a national disaster, social values heldby individuals, religion, role of government, social inequality,attitudes toward democratic values and behaviors; athletics, athleticteams, or lifestyle (e.g., frequency of exercise, alcohol consumption).The public opinion survey can be conducted by a private company, e.g.,media organization (e.g., newspaper, television station, televisionbroadcast company, radio station, or online newspaper or magazine).

In another embodiment, a multi-participant survey can be a survey ofwitnesses of an event. The event can be, e.g., an alleged crime. Thealleged crime can be, e.g., robbery, burglary, assault, battery,shooting, murder, sexual assault, or rape. The event can be, e.g., anaccident. The accident can be, e.g., a traffic accident, an injury, afall, a chemical spill, a hazardous waste spill, a radiation spill, anexplosion, or a workplace accident. The event can be a natural disaster,e.g., tornado, hurricane, typhoon, cyclone, tsunami, blizzard, volcaniceruption, landslide, mudslide, drought, flood, severe thunderstorm,insect infestation, or earthquake. The event can be an attack, e.g., aterrorist attack, a biological weapon attack, a chemical weapon attack,a nuclear attack, or an invasion. In another embodiment, amulti-participant survey comprises a police line-up.

In another embodiment, a first multi-participant survey and a secondmulti-participant survey can be concurrent. In some embodiments, atleast part of the first multi-participant survey occurs while at leastpart of the second multi-participant survey occurs. In one embodiment, afirst multi-participant survey ends before a second multi-participantsurvey begins. In some cases, a plurality of multi-participant surveysis concurrent.

Data from a plurality of multi-participant surveys can be entered intoan electronic device. For example, data from about, at least, less than,or more than 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36,37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54,55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72,73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90,91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 150, 200, 300, 400, 500, 600,700, 800, 900, 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000,10,000, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000,100,000, 200,000, 300,000, 400,000, 500,000, 600,000, 700,000, 800,000,900,000, 1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000,6,000,000, 7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000,30,000,000, 40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000,90,000,000, or 100,000,000 multi-participant surveys can be entered intoan electronic device. Data from 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7,2 to 8, 2 to 9, 2 to 10, about 10 to about 20, about 10 to about 50,about 50 to about 100, about 100 to about 1000, about 1000 to about5000, about 5000 to about 10,000, about 10,000 to about 50,000, about50,000 to about 100,000, about 100,000 to about 500,000, about 500,000to about 1,000,000, about 1,000,000 to about 10,000,000, about10,000,000 to about 50,000,000, or about 50,000,000 to about 100,000,000multi-participant surveys can be entered into an electronic device.

In one embodiment, data from more than one multi-participant survey ofthe same type can be entered into an electronic device. For example,data from more than one clinical trial can be entered into an electronicdevice. In another embodiment, data from more than one multi-participantsurvey of different types can be entered into an electronic device. Forexample, data from a clinical trial and data from a public opinionsurvey can be entered onto an electronic device.

A plurality of multi-participant surveys can comprise surveys conductedby the same individual or group or surveys conducted by differentindividuals or groups.

Participants

The first participant in a first multi-participant survey and the secondparticipant in a second multi-participant can be the same person. Forexample, the same person can participate in two differentmulti-participant surveys, and data from the same person can be enteredinto an electronic device. In one embodiment, the first participant andthe second participant are different people. For example, the data fromthe first participant participating in a first multi-participant surveycan be entered into an electronic device, and data from the secondparticipant participating in the first multi-participant survey can beentered into the device. In one embodiment, data from the firstparticipant participating in a first multi-participant survey can beentered into an electronic device, and data from the second participantparticipating in a second multi-participant survey can be entered intothe device, wherein the first participant and second participant aredifferent people and the first multi-participant survey and the secondmulti-participant survey are different.

Data from a plurality of participants in one or more multi-participantsurveys can be entered into an electronic device. The plurality ofparticipants can be about, at least, less than, or more than 5, 10, 25,50, 75, 100, 150, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000,3000, 4000, 5000, 6000, 7000, 8000, 9000, 10,000, 20,000, 30,000,40,000, 50,000, 60,000, 70,000, 80,000, 90,000, 100,000, 200,000,300,000, 400,000, 500,000, 600,000, 700,000, 800,000, 900,000,1,000,000, 2,000,000, 3,000,000, 4,000,000, 5,000,000, 6,000,000,7,000,000, 8,000,000, 9,000,000, 10,000,000, 20,000,000, 30,000,000,40,000,000, 50,000,000, 60,000,000, 70,000,000, 80,000,000, 90,000,000,or 100,000,000 participants in one or more multi-participant surveys.The plurality of participants can be about 100 to about 1000, about 1000to about 5000, about 5000 to about 10,000, about 10,000 to about 50,000,about 50,000 to about 100,000, about 100,000 to about 500,000, about500,000 to about 1,000,000, about 1,000,000 to about 10,000,000, about10,000,000 to about 50,000,000, or about 50,000,000 to about 100,000,000participants in one or more multi-participant surveys.

A first and/or second participant can enter data into an electronicdevice. In some embodiments, one or more third parties enter data fromthe first and/or second participant into an electronic device. In oneembodiment, the one or more third parties are a relative or healthcareprovider. A relative can be, e.g., spouse (husband or wife), sister,brother, aunt, uncle, grandfather, grandmother, child, or cousin.Healthcare providers are described herein.

In one embodiment, a participant is male or a female. In anotherembodiment, a participant is a newborn, an infant, a child, a teenager,a young adult, an adult, or an elderly person. In another embodiment, aparticipant can be about, at least, more than, or less than 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41,42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59,60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77,78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95,96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110,111, 112, 113, 114, 115, 116, 117, 118, 119, or 120 years old. In somecases, the age of the participants is about 1 day to about 1 year old,about 1 year old to about 4 years old, about 5 years old to about 10years old, about 10 years old to about 12 years old, about 13 years oldto about 19 years old, about 20 years old to about 29 years old, about30 years old to about 39 years old, about 40 years old to about 49 yearsold, about 50 years old to about 59 years old, about 60 years old toabout 69 years old, about 70 years old to about 80 years old, about 80years old to about 90 years old, about 90 years old to about 100 yearsold, about 100 years old to about 110 years old, or about 110 years oldto about 120 years old. In another embodiment, a participant is enrolledin a clinical trial. In another embodiment, a participant is pregnant oris suspected of being pregnant (e.g., pregnant with a single fetus,twins, triplets, etc.). In another embodiment, a participant can have acondition, e.g., cancer, autoimmune disease, neurological disorder, ordiabetes. In another embodiment, a participant can have an infectiousdisease, e.g., a bacterial infection, fungal infection, or viralinfection, e.g., influenza or AIDS.

Data

Data that can be entered into an electronic device provided herein cantake a variety of forms. Data entered into an electronic device can beused for a variety of purposes.

The data can be clinical trial data. Clinical trial data can includedata gathered for the principle purpose of a clinical trial. Forexample, clinical trial data can include pain levels experienced bysubjects in a pain medication clinical trial or craving levels in ananti-smoking medication clinical trial. Clinical trial data entered intoa device can include, e.g., gender of a subject, height, weight, bodyfat percentage, body fat index, hair color, Body Mass Index (BMI), hoursof sleep per day, sleep quality index score, bowel movement schedule,pain index score, pain scale score, pain threshold test result, hearingtest result, optometry exam result, appetite level, hunger scale score,number of calories consumed per day, volume of liquid consumed per day,thirst scale score, libido scale score, erection frequency, energylevel, activity level, exercise level, activity type, activity schedule,well-being, nausea frequency, psychological stress level, depressionlevel score, intelligence quotient test result, mental skill testresult, exercise test result, fatigue level, disease severity, PSAlevel, cholesterol level, blood pressure, systolic blood pressure,diastolic blood pressure, cardiac stress test result, blood glucoselevel, heart rate, spirometry test result, lung volume measurement, lungdiffusion capacity, VO₂ max, oximeter reading, biomarker level, presenceor absence of a biomarker, biopsy result, time spent in sedentaryactivity per day, urination frequency, urination amount, frequency ofsocial contacts, duration of social contacts, the time of the year, andthe day of the week. The clinical trial data can be self-reports ofclinical trial data including subjective reports, such as painreduction, objective symptom reporting, such as bowel movement orasthmatic episode or cognitive measures, such as arithmetic tasks orreaction time. An electronic device can be configured to synchronizewith any portable physiological measurement device to gather data from,or communicate with, the physiological device. Data can be derived fromPhase 0, Phase 1, Phase 2, Phase 3, or Phase 4 of a clinical trial.

The clinical trial results can be clinical tests comprising tests oftissues and/or bodily fluids comprising blood tests, fatty acid tests,urine tests, plasma tests, enzyme tests, pregnancy tests, DNA tests, orcytogenetics tests, among others.

In one embodiment, an electronic device can be used to track complianceinformation for a plurality of multi-participant studies, e.g., clinicaltrials. For example, historical protocol data can be entered into anelectronic device. Historical protocol data can include data specifyinga research protocol of an earlier clinical trial. Examples of historicalprotocol data can include questions posed to a subject, frequency ofprompting of a subject during various times of a day or week, timeallowed for subjects to respond to one or more questions, requirementsof subject behavior, and conditions mandating removal of a subject fromspecific analyses or from participation in a clinical trial. Methods ofdetecting, predicting, and enhancing subject compliance, e.g., subjectcompliance with a research protocol, are described, e.g., in U.S. Pat.Nos. 6,879,970, 7,415,447, 7,873,589, 8,065,180, and 8,145,519, whichare herein incorporated by reference in their entireties. Compliance caninclude complete compliance, good compliance, non-compliance, or minornon-compliance.

In some cases, data entered into an electronic device can be used todetermine or predict fraud with a research protocol in a clinical trial.Methods and devices for detecting or predicting fraud are described inU.S. Pat. Nos. 6,879,970, 7,415,447, and 7,873,589, which are hereinincorporated by reference in their entireties. Data determined orpredicted to be fraudulent can be excluded from a data set. In somecases, data determined to be fraudulent can be removed from anelectronic device, a staging data repository, or a study datarepository. In some cases, the fraud is committed by a subject in amulti-participant survey (e.g., clinical trial). In some cases, thefraud is committed by a sponsor of a multi-participant survey (e.g.,clinical trial).

In some cases, data entered into an electronic device can be evaluatedto determine or predict the validity of the data (e.g., whether entereddata is within an acceptable range). Data determined or predicted to beinvalid can be excluded from a data set. In some cases, data determinedor predicted to be invalid can be removed from an electronic device, astaging data repository, and/or a study data repository. Methods anddevices for detecting or predicting invalid data are described, e.g., inU.S. Pat. Nos. 6,879,970, 7,415,447, 7,873,589, 8,065,180, and8,145,519, which are herein incorporated by reference in theirentireties.

Compliance data can be entered into an electronic device. Compliancedata can be data that relates to the circumstances under which clinicaltrial data are collected or other data pertaining to characteristics ofclinical trial data. Examples of compliance data include timeliness,consistency with other collected data, proximity of the data to anexpected data range, and completeness of the data.

An electronic device can track aspects of its use, which can result in acomprehensive record of subject compliance with a research protocol.Clinical trial staff can collect data regarding subject compliance bytracking a variety of different components of compliance. Clinical trialstaff can check compliance against empirically derived algorithms anddecision rules of compliance. These empirically derived algorithms anddecision rules allow the disclosed invention to examine the data fornonintuitive and complex combinations of predictors to proactivelydetermine whether the observed pattern of interaction with the portableelectronic device suggests noncompliance.

An electronic device can conduct ongoing compliance checks and provide asubject feedback about his or her performance. For example, logicalpsychometric or other inconsistencies can be determined by an electronicdevice. Actions of an electronic device can be processed according todecision rules. An electronic device can vary its behavior based on thesubject's behavior. For example, prompt frequency can be delayed orincreased, or louder prompts can be provided. Vibration or visual alertscan be generated.

Compliance checks can be performed on a server and feedback can be givento a subject by clinical trial staff; the feedback can be face-to-faceor remote.

When the multi-participant survey is a clinical trial, data can be usedto track and enhance subject compliance with protocol requirements andprovide evaluability data related to subject performance in the clinicaltrial. For example, an empirically derived set of algorithms anddecision rules can be used to predict, track and enhance subjectcompliance with research protocols in a clinical trial. Algorithms anddecision rules can be used for analysis of different types of subjectnoncompliance with research protocols.

Algorithms for detecting or predicting subject compliance, fraud, ordata invalidity, and methods for developing algorithms for detecting orpredicting subject compliance, fraud, or data invalidity, are describedin U.S. Patent Nos. 6,879,970, 7,415,447, 7,873,589, 8,065,180, and8,145,519, which are herein incorporated by reference in theirentireties.

In some cases, the data provided herein can be used to predict thereliability of endpoints in supporting one or more medical labelingclaims. Methods, systems, and devices for predicting the reliability ofendpoints in supporting one or more medical labeling claims aredescribed, e.g., in U.S. Patent Application Publication No. 2100023346,which is herein incorporated by reference in its entirety.

Healthcare Provider

In some embodiments, one or more healthcare providers enter data into anelectronic device or provide an electronic device to a subject. Ahealthcare provider can be, e.g., a nurse, a physician (e.g., generalpractitioner or specialist) a physician assistant, a surgeon, apsychiatrist, a psychologist, clinical psychologist, clinical socialworker, mental health nurse practitioner, marriage or family therapist,obstetrician, obstetrical nurse, midwife, nurse practitioner,geriatrician, geriatric nurse, geriatric aide, surgical practitioner,anesthesiologist, nurse anesthetist, surgical nurse, operatingdepartment practitioner, anesthetic technician, surgical technologist,physiotherapist, orthotist, prosthetist, recreational therapist, dentalhygienist, dentist, podiatrist, pedorthist, chiropractor, a medicaltechnician, a pharmacist, dietitian, therapist, clinical officer,phlebotomist, physical therapist, social worker, respiratory therapist,occupational therapist, audiologist, speech pathologist, optometrist,emergency medical technician, paramedic, medical laboratory technician,radiography, medical prosthetic technician, epidemiologist, or healthinspector.

A healthcare provider can enter data into an electronic device for afirst clinical trial, and a subject can enter data into the electronicdevice for a second clinical trial. A healthcare provider can enter datainto an electronic device for a first clinical trial and a secondclinical trial. In some embodiments, a healthcare provider does notenter data into an electronic device that is configured to accept datafrom a plurality of multi-participant studies. Healthcare providers canenter data in an electronic device for a plurality of multi-participantstudies.

Ranges can be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. Itwill be further understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint. The term “about” as used herein refers to a rangethat is 15% plus or minus from a stated numerical value within thecontext of the particular usage. For example, about 10 would include arange from 8.5 to 11.5.

EXAMPLE Example 1

A first subject enrolls in a first clinical trial for a firstpharmaceutical composition. The first subject visits a clinic and isprovided doses of the first pharmaceutical composition. The firstsubject is also provided a portable electronic device by a healthcareprovider for recording data regarding the first subject's physiologicalresponses to the pharmaceutical composition. The portable electronicdevice is configured to accept data entered by the first subjectregarding the first clinical trial. The portable electronic device isalso configured to accept data related to a second clinical trial for asecond pharmaceutical composition. The first clinical trial lasts fornine months. The first subject enters data regarding the first clinicaltrial into the portable electronic device. The first subject returns theportable electronic device to the healthcare provider at the end of thefirst clinical trial. The healthcare provider then provides theelectronic device to a second subject enrolled in the second clinicaltrial. The second subject enters data related to the second clinicaltrial into the portable electronic device. At the end of the secondclinical trial, the second subject returns the portable electronicdevice to the healthcare provider.

The electronic device communicates the data from the first subject inthe first clinical trial to a staging data repository at the end of thefirst clinical trial. The electronic device also communicates the datafrom the second subject in the second clinical trial to the staging datarepository at the end of the second clinical trial. The data from thefirst clinical trial is transferred to a first study data repository andthe data from the second clinical trial is transferred to a second studydata repository.

Example 2

A polling company recruits five thousand volunteers in a “swing state”to offer their opinions regarding federal and state elections inNovember of an election year. The company distributes portableelectronic devices to the five thousand volunteers in January of theelection year. The polling company sends two types of questionnaires tothe volunteers at random times and/or before or after certain events.One type of questionnaire contains questions concerning federalelections; the other type of questionnaire contains questions concerningstate elections. Reponses to federal election questionnaires areidentified electronically as being related to federal elections;responses to state election questionnaires are identified electronicallyas being related to state elections. Responses are entered by a touchscreen. An event can include a debate, caucus, primary election, speech,convention, scandal, major world event, natural disaster, withdrawal ofa candidate, etc. Volunteers must respond to each questionnaire within aspecified time window after receiving the questionnaire; if thevolunteer does not respond before the time window closes, the volunteerscannot enter responses for that questionnaire into the electronicdevice.

Data entered into the portable electronic devices are immediatelytransmitted to a staging data repository once the time window forresponding to a questionnaire closes. Data concerning state electionquestionnaires is then transmitted from the staging data repository tothe state election study data repository. Data concerning federalelection questionnaires is transmitted from the staging data repositoryto a federal election study data repository. Local election study datarepositories in electronic communication with the staging datarepository are locked.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A method for managing data on an electronic device, wherein the dataare from a plurality of multi-participant surveys, wherein the data aremanaged for analysis, the method comprising: a. entering data from afirst participant in a first multi-participant survey into theelectronic device, wherein the data from the first participant areidentified for analysis as being from the first participant or as beingfrom the first multi-participant survey; b. entering data from a secondparticipant in a second multi-participant survey into the electronicdevice, wherein the first multi-participant survey is different from thesecond multi-participant survey, and wherein the data from the secondparticipant are identified for analysis as being from the secondparticipant or as being from the second multi-participant survey; and c.aggregating the data from the first participant or the data from thefirst multi-participant survey for analysis, and aggregating the datafrom the second participant or the data from the secondmulti-participant survey for analysis.
 2. (canceled)
 3. The method ofclaim 1, further comprising recording the data from the firstparticipant in the first multi-participant survey and the data from thesecond participant in the second multi-participant survey on theelectronic device. 4-7. (canceled)
 8. The method of claim 1, wherein theelectronic device is connected to the Internet. 9-12. (canceled)
 13. Themethod of claim 1, wherein the first participant enters the data fromthe first multi-participant survey into the electronic device, and thesecond participant enters the data from the second multi-participantsurvey into the electronic device.
 14. The method of claim 1, wherein afirst individual enters the data from the first participant in the firstmulti-participant survey into the device, and a second individual entersthe data from second participant in the second multi-participant surveyinto the device. 15-16. (canceled)
 17. The method of claim 1, furthercomprising entering data from at least 3, 4, 5, 6, 7, 8, 9, 10, 50, 100,1000, 10,000, 100,000, or 1,000,000 multi-participant surveys into thedevice.
 18. The method of claim 1, wherein a plurality of participantsparticipates in the first multi-participant survey and a plurality ofparticipants participates in the second multi-participant survey. 19.The method of claim 1, wherein the electronic device is in electroniccommunication with a staging data repository.
 20. (canceled)
 21. Themethod of claim 19, further comprising transmitting the data identifiedas being from the first participant in the first multi-participantsurvey to the staging data repository and transmitting the dataidentified as being from the second participant in the secondmulti-participant survey to the staging data repository.
 22. The methodof claim 19, further comprising transmitting the data identified asbeing from the first multi-participant survey to the staging datarepository and transmitting the data identified as being from the secondmulti-participant survey to the staging data repository.
 23. The methodof claim 19, wherein the staging data repository is in electroniccommunication with a plurality of study data repositories, wherein theplurality of study data repositories comprises a first study datarepository and a second study data repository.
 24. The method of claim23, further comprising transferring, from the staging data repository,the data identified as being from the first participant in the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second participant in the secondmulti-participant survey to the second study data repository.
 25. Themethod of claim 23, further comprising transferring, from the stagingdata repository, the data identified as being from the firstmulti-participant survey to the first study data repository and the dataidentified as being from the second multi-participant survey to thesecond study data repository.
 26. (canceled)
 27. The method of claim 23,further comprising adding a new study data repository to the pluralityof study data repositories, wherein the new study data repository is inelectronic communication with the staging data repository.
 28. Themethod of claim 23, wherein the plurality of study data repositoriescomprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 50, 100, 1000, 10,000,100,000, or 1,000,000 study data repositories.
 29. The method of claim1, wherein the plurality of multi-participant surveys is a plurality ofclinical trials, a plurality of market research surveys, or a pluralityof political research surveys. 30-31. (canceled)
 32. The method of claim1, further comprising providing the electronic device to a site, whereina plurality of participants communicates with the site. 33-37.(canceled)
 38. The method of claim 23, wherein the data identified asbeing from the first participant in the first multi-participant surveyare transferred from the staging data repository to the second studydata repository, further comprising transferring, from the second studydata repository to the first study data repository, the data identifiedas being from the first participant in the first multi-participantsurvey that were transferred from the staging data repository to thesecond study data repository.
 39. A computer readable medium havingstored thereon sequences of instructions, which, when executed by acomputer system, cause the computer system to perform: a. accepting datafrom a first participant in a first multi-participant survey in anelectronic device, wherein the data from the first participant areidentified for analysis as being from the first participant or as beingfrom the first multi-participant survey; b. accepting data from a secondparticipant in a second multi-participant survey in the electronicdevice, wherein the first multi-participant survey is different from thesecond multi-participant survey, and wherein the data from the secondparticipant are identified for analysis as being from the secondparticipant or as being from the second multi-participant survey; and c.aggregating the data from the first participant or the data from thefirst multi-participant survey for analysis, and aggregating the datafrom the second participant or the data from the secondmulti-participant survey for analysis. 40-74. (canceled)
 75. A systemfor managing data from a plurality of multi-participant surveys, thesystem comprising computer readable instructions for: a. accepting datafrom a first participant in a first multi-participant survey in anelectronic device, wherein the data from the first participant areidentified for analysis as being from the first participant or as beingfrom the first multi-participant survey; b. accepting data from a secondparticipant in a second multi-participant survey in the electronicdevice, wherein the first multi-participant survey is different from thesecond multi-participant survey, and wherein the data from the secondparticipant are identified for analysis as being from the secondparticipant or as being from the second multi-participant survey; and c.aggregating the data from the first participant or the data from thefirst multi-participant survey for analysis, and aggregating the datafrom the second participant or the data from the secondmulti-participant survey for analysis. 76-110. (canceled)
 111. A systemfor managing data from a plurality of multi-participant surveys, saidsystem comprising: a. an electronic device, wherein said electronicdevice comprises: i. logic for receiving data from a first participantin a first multi-participant survey, wherein the data from the firstparticipant are identified for analysis as being from the firstparticipant or as being from the first multi-participant survey; ii.logic for receiving data from a second participant in a secondmulti-participant survey into the electronic device, wherein the firstmulti-participant survey is different from the second multi-participantsurvey, and wherein the data from the second participant are identifiedfor analysis as being from the second participant or as being from thesecond multi-participant survey; iii. logic for aggregating the datafrom the first participant or the data from the first multi-participantsurvey for analysis; iv. logic for aggregating the data from the secondparticipant or the data from the second multi-participant survey foranalysis; and v. storage adapted to store the aggregated data from thefirst participant or the data from the first multi-participant surveyand the aggregated data from the second participant or the data from thesecond multi-participant survey; b. a staging data repositorycomprising: i. an interface for communication with said electronicdevice; ii. logic for receiving data from said electronic device throughsaid communication interface; and iii. storage adapted to receive theaggregated data from the first participant or the data from the firstmulti-participant survey and the aggregated data from the secondparticipant or the data from the second multi-participant survey; and c.a plurality of study data repositories, where the plurality of studydata repositories comprises: i. an interface for communication with saidstaging data repository; ii. logic for receiving data from said stagingdata repository; and iii. logic for processing data from said stagingdata repository. 112-147. (canceled)